Mental Health

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

A version of this article first appeared on Medscape.com.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release. 

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.

A version of this article first appeared on Medscape.com.

Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release. 

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.

A version of this article first appeared on Medscape.com.

Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.

The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.

“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release. 

“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.

The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.

This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.

A version of this article first appeared on Medscape.com.

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

A version of this article first appeared on Medscape.com.

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

A version of this article first appeared on Medscape.com.

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

A version of this article first appeared on Medscape.com.

Medication nonadherence is common with oral antipsychotic formulations, resulting in relapse, increased morbidity, and more frequent psychiatric hospitalization.^1-7 Psychiatric hospitalization and illness decompensation is costly to health care systems and leads to reduced quality of life for veterans and families.^6,7 Long-acting injectable antipsychotics (LAIAs) were developed to enhance antipsychotic adherence and improve patient outcomes, including reduced psychiatric hospitalization.^8-12

Little outcomes data exist comparing LAIAs, including biweekly risperidone microspheres and monthly paliperidone palmitate.^10-13 Risperidone microspheres require a 3-week oral crossover and are administered every 2 weeks, whereas paliperidone palmitate does not require an oral crossover and is administered every 4 weeks. The paliperidone palmitate loading regimen replaces an oral crossover.

The primary objective of this study was to compare the number of psychiatric hospitalizations between veterans administered risperidone microspheres and those on paliperidone palmitate pre- and post-LAIA initiation. Secondary objectives were to assess rehospitalization rates between patients taking risperidone microspheres and paliperidone palmitate, reduction in pre- and posthospitalization rates with LAIAs, and medication adherence.

Methods

This observational study with a retrospective cohort design was conducted at the Veterans Affairs Loma Linda Healthcare System (VALLHS) in California. We examined veterans who were initiated on LAIAs risperidone microspheres or paliperidone palmitate from January 01, 2016 through December 31, 2018. Veterans who were aged ≥ 18 years and received ≥ 2 injections of either risperidone microspheres or paliperidone palmitate during the study period were included. Veterans were excluded if they had received < 2 doses of either LAIA, received the LAIA outside of the review period, were nonadherent to risperidone crossover if they received risperidone microspheres, or transferred their care to another facility. At VALLHS, LAIA injections are administered by a nurse, and veterans must travel to the facility to receive the injections.

Extracted patient chart elements included participant demographics; diagnoses; comorbid alcohol, nicotine, opioid, or other substance use; duration on LAIA; psychiatric hospitalizations pre- and postinitiation of the LAIA; medication adherence; and medication discontinuation based on clinician documentation and clinic orders (Table 1).

Data Analysis

Patient demographics were analyzed using descriptive statistics and experimental comparisons between the risperidone microspheres and paliperidone palmitate groups to assess baseline differences between groups. Psychiatric hospitalizations pre- and post-LAIA were analyzed with parallel group (between veterans–independent groups) and pre-post (within veterans–dependent groups) designs. Index hospitalizations were examined for a period equivalent to the length of time veterans were on the LAIA. Psychiatric rehospitalization rates were analyzed for patients who had index hospitalizations and were rehospitalized for any period when they were receiving the LAIA. Incidences of pre- and post-LAIA hospitalizations were calculated in 100 person-years.

Parallel-group analysis was analyzed using the χ² and Mann-Whitney U tests. Pre-post analyses were analyzed using the Wilcoxon rank sum test. P was set at < .05 for statistical significance.

Results

We screened 111 veterans, and 97 were included in this study (risperidone microspheres, 44; paliperidone palmitate, 53). Mean (SD) age was 46 (13.8) years, 92% were male, 38% were White, 94% were diagnosed with schizophrenia or schizoaffective disorder, and 11% were homeless. Substance use was documented as 52% for nicotine products, 40% for alcohol, 31% for cannabis, 27% for methamphetamine, 7% for cocaine, and 3% for opioids. Cannabis, methamphetamine, cocaine, and opioid use were based on clinician documentation and listed as active diagnoses at the time of LAIA initiation. Statistical significance was found in index hospitalizations P = .009) and history of cocaine use disorder (6.8% vs 7.5%, P < .001).

Veterans administered risperidone microspheres had fewer mean (SD) post-LAIA hospitalizations (0.4 [1.0] vs 0.9 [1.5]; P = .02) and were less likely to be rehospitalized (22.7% vs 47.2%, P = .01) compared with paliperidone palmitate. However, veterans taking risperidone microspheres had a shorter mean (SD) treatment duration (41.6 [40.2] vs 58.2 [45.7] weeks, P = .04) compared with paliperidone palmitate, mainly because patients switched to a different LAIA or oral antipsychotic. No differences were detected in nonadherence and discontinuation between risperidone microspheres and paliperidone palmitate. All veterans in the risperidone microspheres group adhered to oral risperidone crossover with an average 87.8% days covered (Table 2).

Discussion

The main finding of this study was that initiation of LAIAs significantly reduced hospitalizations. Veterans taking risperidone microspheres had higher index hospitalizations and lower posttreatment hospitalizations compared with paliperidone palmitate. We found that patients initiated on risperidone microspheres had more hospitalizations before use of a LAIA than those initiated on paliperidone palmitate. Risperidone microspheres reduced the number of hospitalization post-LAIA significantly more than paliperidone palmitate. We also found that veterans taking risperidone microspheres were on the medication for less mean (SD) time than those on paliperidone palmitate (41.6 [40.2] vs 58.2 [45.7] weeks; P = .04).

To our knowledge, this is one of the few studies that compared outcomes of psychiatric hospitalizations, medication adherence, and treatment discontinuation between risperidone microspheres and paliperidone palmitate, specifically in a veteran population.^16-19 Limosin and colleagues aimed to compare length of stay during the initial hospitalization, rehospitalization risk, and treatment duration between risperidone microspheres and paliperidone palmitate in patients with schizophrenia.¹⁶ These researchers detected no differences in initial hospitalization duration and time to rehospitalization between risperidone microspheres and paliperidone palmitate.¹⁶ The study revealed a more favorable trend in time to discontinuation for paliperidone palmitate, but switching between LAIAs might have confounded the data.¹⁶ The authors note that their study lacked power, and patients on paliperidone palmitate had significantly more nonpsychiatric comorbidities.¹⁶ Joshi and colleagues looked at adherence, medication discontinuation, hospitalization rates, emergency department visits, and hospitalization costs between risperidone microspheres and paliperidone palmitate in patients identified in Truven MarketScan Commercial, Medicare Supplemental, and Medicaid Multi-State insurance databases.¹⁷ The authors found paliperidone palmitate to be superior in all objectives with better adherence, lower discontinuation rates, less likelihood of hospitalization, fewer emergency department visits, and lower hospitalization costs compared with risperidone microspheres.¹⁷ Korell and colleagues aimed to establish reference ranges for plasma concentrations of risperidone and paliperidone among adherent patients.¹⁸

The results in our study are somewhat unexpected in part because of the close relationship between risperidone and paliperidone. Risperidone is converted to paliperidone (9-OH-risperidone) via hepatic cytochrome P450 2D6. Although the molecules do not have identical pharmacologic profiles, it is accepted that they are similar enough that risperidone can establish oral tolerability when transitioning therapy to paliperidone palmitate and vice versa.²⁴ Although the active moiety in risperidone microspheres and paliperidone palmitate is similar, the dosing interval for risperidone microspheres is 2 weeks compared with 4 weeks with paliperidone palmitate. One potential explanation as to why veterans started on risperidone microspheres experienced better outcomes is because they had twice as many office visits with the health care team. Facility procedures dictate veterans receive the LAIA at an on-site clinic. During the visits, a licensed vocational nurse administers the injection and monitors the patient for 15 to 30 minutes afterward.

Despite new LAIAs coming to market, high-quality data examining potential differences in treatment outcomes among agents are limited. This is problematic for clinicians who want to optimize care by understanding how administration schedules or other aspects of LAIA use could modify treatment outcomes. Our results suggest that an advantage might exist in selecting an agent with a more frequent administration schedule, at least initially. This could allow for close monitoring and regular therapeutic contact, which could improve short-term outcomes. This conclusion is supported by meta-analyses, randomized controlled trials, and conceptual articles conducted by Wehring and colleagues, Berwaerts and colleagues, and Parellada and colleagues, respectively, who examined patients on different LAIAs and contact with health care professionals as part of their research.^26-28 These researchers concluded that patients who had regular contact with a health care professional had better outcomes when initiated on a LAIA.^26-28

Limitations

There are several limitations in this study. Retrospective and observational methods introduce risks of bias and confounding variables. Sample size might have limited statistical power to detect differences. Veterans might have had undocumented pre- or posthospitalizations at other institutions, which was not accounted for and lack of rehospitalization is not conclusive of a positive outcome. Institutions could improve on our study and help to fill gaps in comparative data by conducting larger analyses over longer periods and including more LAIA agents.

Conclusions

Although veterans that were administered risperidone microspheres had a shorter treatment duration, they were less likely to be rehospitalized, had a fewer mean number of post-LAIA hospitalizations, and had a larger difference in incidence in 100 person-years compared with veterans on paliperidone palmitate. Nonadherence and discontinuation rates were comparable between risperidone microspheres and paliperidone palmitate. Future studies could aim to further clarify differences in outcomes among agents or administration schedules.

Medication nonadherence is common with oral antipsychotic formulations, resulting in relapse, increased morbidity, and more frequent psychiatric hospitalization.^1-7 Psychiatric hospitalization and illness decompensation is costly to health care systems and leads to reduced quality of life for veterans and families.^6,7 Long-acting injectable antipsychotics (LAIAs) were developed to enhance antipsychotic adherence and improve patient outcomes, including reduced psychiatric hospitalization.^8-12

Little outcomes data exist comparing LAIAs, including biweekly risperidone microspheres and monthly paliperidone palmitate.^10-13 Risperidone microspheres require a 3-week oral crossover and are administered every 2 weeks, whereas paliperidone palmitate does not require an oral crossover and is administered every 4 weeks. The paliperidone palmitate loading regimen replaces an oral crossover.

The primary objective of this study was to compare the number of psychiatric hospitalizations between veterans administered risperidone microspheres and those on paliperidone palmitate pre- and post-LAIA initiation. Secondary objectives were to assess rehospitalization rates between patients taking risperidone microspheres and paliperidone palmitate, reduction in pre- and posthospitalization rates with LAIAs, and medication adherence.

Methods

This observational study with a retrospective cohort design was conducted at the Veterans Affairs Loma Linda Healthcare System (VALLHS) in California. We examined veterans who were initiated on LAIAs risperidone microspheres or paliperidone palmitate from January 01, 2016 through December 31, 2018. Veterans who were aged ≥ 18 years and received ≥ 2 injections of either risperidone microspheres or paliperidone palmitate during the study period were included. Veterans were excluded if they had received < 2 doses of either LAIA, received the LAIA outside of the review period, were nonadherent to risperidone crossover if they received risperidone microspheres, or transferred their care to another facility. At VALLHS, LAIA injections are administered by a nurse, and veterans must travel to the facility to receive the injections.

Extracted patient chart elements included participant demographics; diagnoses; comorbid alcohol, nicotine, opioid, or other substance use; duration on LAIA; psychiatric hospitalizations pre- and postinitiation of the LAIA; medication adherence; and medication discontinuation based on clinician documentation and clinic orders (Table 1).

Data Analysis

Patient demographics were analyzed using descriptive statistics and experimental comparisons between the risperidone microspheres and paliperidone palmitate groups to assess baseline differences between groups. Psychiatric hospitalizations pre- and post-LAIA were analyzed with parallel group (between veterans–independent groups) and pre-post (within veterans–dependent groups) designs. Index hospitalizations were examined for a period equivalent to the length of time veterans were on the LAIA. Psychiatric rehospitalization rates were analyzed for patients who had index hospitalizations and were rehospitalized for any period when they were receiving the LAIA. Incidences of pre- and post-LAIA hospitalizations were calculated in 100 person-years.

Parallel-group analysis was analyzed using the χ² and Mann-Whitney U tests. Pre-post analyses were analyzed using the Wilcoxon rank sum test. P was set at < .05 for statistical significance.

Results

We screened 111 veterans, and 97 were included in this study (risperidone microspheres, 44; paliperidone palmitate, 53). Mean (SD) age was 46 (13.8) years, 92% were male, 38% were White, 94% were diagnosed with schizophrenia or schizoaffective disorder, and 11% were homeless. Substance use was documented as 52% for nicotine products, 40% for alcohol, 31% for cannabis, 27% for methamphetamine, 7% for cocaine, and 3% for opioids. Cannabis, methamphetamine, cocaine, and opioid use were based on clinician documentation and listed as active diagnoses at the time of LAIA initiation. Statistical significance was found in index hospitalizations P = .009) and history of cocaine use disorder (6.8% vs 7.5%, P < .001).

Veterans administered risperidone microspheres had fewer mean (SD) post-LAIA hospitalizations (0.4 [1.0] vs 0.9 [1.5]; P = .02) and were less likely to be rehospitalized (22.7% vs 47.2%, P = .01) compared with paliperidone palmitate. However, veterans taking risperidone microspheres had a shorter mean (SD) treatment duration (41.6 [40.2] vs 58.2 [45.7] weeks, P = .04) compared with paliperidone palmitate, mainly because patients switched to a different LAIA or oral antipsychotic. No differences were detected in nonadherence and discontinuation between risperidone microspheres and paliperidone palmitate. All veterans in the risperidone microspheres group adhered to oral risperidone crossover with an average 87.8% days covered (Table 2).

Discussion

The main finding of this study was that initiation of LAIAs significantly reduced hospitalizations. Veterans taking risperidone microspheres had higher index hospitalizations and lower posttreatment hospitalizations compared with paliperidone palmitate. We found that patients initiated on risperidone microspheres had more hospitalizations before use of a LAIA than those initiated on paliperidone palmitate. Risperidone microspheres reduced the number of hospitalization post-LAIA significantly more than paliperidone palmitate. We also found that veterans taking risperidone microspheres were on the medication for less mean (SD) time than those on paliperidone palmitate (41.6 [40.2] vs 58.2 [45.7] weeks; P = .04).

To our knowledge, this is one of the few studies that compared outcomes of psychiatric hospitalizations, medication adherence, and treatment discontinuation between risperidone microspheres and paliperidone palmitate, specifically in a veteran population.^16-19 Limosin and colleagues aimed to compare length of stay during the initial hospitalization, rehospitalization risk, and treatment duration between risperidone microspheres and paliperidone palmitate in patients with schizophrenia.¹⁶ These researchers detected no differences in initial hospitalization duration and time to rehospitalization between risperidone microspheres and paliperidone palmitate.¹⁶ The study revealed a more favorable trend in time to discontinuation for paliperidone palmitate, but switching between LAIAs might have confounded the data.¹⁶ The authors note that their study lacked power, and patients on paliperidone palmitate had significantly more nonpsychiatric comorbidities.¹⁶ Joshi and colleagues looked at adherence, medication discontinuation, hospitalization rates, emergency department visits, and hospitalization costs between risperidone microspheres and paliperidone palmitate in patients identified in Truven MarketScan Commercial, Medicare Supplemental, and Medicaid Multi-State insurance databases.¹⁷ The authors found paliperidone palmitate to be superior in all objectives with better adherence, lower discontinuation rates, less likelihood of hospitalization, fewer emergency department visits, and lower hospitalization costs compared with risperidone microspheres.¹⁷ Korell and colleagues aimed to establish reference ranges for plasma concentrations of risperidone and paliperidone among adherent patients.¹⁸

The results in our study are somewhat unexpected in part because of the close relationship between risperidone and paliperidone. Risperidone is converted to paliperidone (9-OH-risperidone) via hepatic cytochrome P450 2D6. Although the molecules do not have identical pharmacologic profiles, it is accepted that they are similar enough that risperidone can establish oral tolerability when transitioning therapy to paliperidone palmitate and vice versa.²⁴ Although the active moiety in risperidone microspheres and paliperidone palmitate is similar, the dosing interval for risperidone microspheres is 2 weeks compared with 4 weeks with paliperidone palmitate. One potential explanation as to why veterans started on risperidone microspheres experienced better outcomes is because they had twice as many office visits with the health care team. Facility procedures dictate veterans receive the LAIA at an on-site clinic. During the visits, a licensed vocational nurse administers the injection and monitors the patient for 15 to 30 minutes afterward.

Despite new LAIAs coming to market, high-quality data examining potential differences in treatment outcomes among agents are limited. This is problematic for clinicians who want to optimize care by understanding how administration schedules or other aspects of LAIA use could modify treatment outcomes. Our results suggest that an advantage might exist in selecting an agent with a more frequent administration schedule, at least initially. This could allow for close monitoring and regular therapeutic contact, which could improve short-term outcomes. This conclusion is supported by meta-analyses, randomized controlled trials, and conceptual articles conducted by Wehring and colleagues, Berwaerts and colleagues, and Parellada and colleagues, respectively, who examined patients on different LAIAs and contact with health care professionals as part of their research.^26-28 These researchers concluded that patients who had regular contact with a health care professional had better outcomes when initiated on a LAIA.^26-28

Limitations

There are several limitations in this study. Retrospective and observational methods introduce risks of bias and confounding variables. Sample size might have limited statistical power to detect differences. Veterans might have had undocumented pre- or posthospitalizations at other institutions, which was not accounted for and lack of rehospitalization is not conclusive of a positive outcome. Institutions could improve on our study and help to fill gaps in comparative data by conducting larger analyses over longer periods and including more LAIA agents.

Conclusions

Although veterans that were administered risperidone microspheres had a shorter treatment duration, they were less likely to be rehospitalized, had a fewer mean number of post-LAIA hospitalizations, and had a larger difference in incidence in 100 person-years compared with veterans on paliperidone palmitate. Nonadherence and discontinuation rates were comparable between risperidone microspheres and paliperidone palmitate. Future studies could aim to further clarify differences in outcomes among agents or administration schedules.

Medication nonadherence is common with oral antipsychotic formulations, resulting in relapse, increased morbidity, and more frequent psychiatric hospitalization.^1-7 Psychiatric hospitalization and illness decompensation is costly to health care systems and leads to reduced quality of life for veterans and families.^6,7 Long-acting injectable antipsychotics (LAIAs) were developed to enhance antipsychotic adherence and improve patient outcomes, including reduced psychiatric hospitalization.^8-12

Little outcomes data exist comparing LAIAs, including biweekly risperidone microspheres and monthly paliperidone palmitate.^10-13 Risperidone microspheres require a 3-week oral crossover and are administered every 2 weeks, whereas paliperidone palmitate does not require an oral crossover and is administered every 4 weeks. The paliperidone palmitate loading regimen replaces an oral crossover.

The primary objective of this study was to compare the number of psychiatric hospitalizations between veterans administered risperidone microspheres and those on paliperidone palmitate pre- and post-LAIA initiation. Secondary objectives were to assess rehospitalization rates between patients taking risperidone microspheres and paliperidone palmitate, reduction in pre- and posthospitalization rates with LAIAs, and medication adherence.

Methods

This observational study with a retrospective cohort design was conducted at the Veterans Affairs Loma Linda Healthcare System (VALLHS) in California. We examined veterans who were initiated on LAIAs risperidone microspheres or paliperidone palmitate from January 01, 2016 through December 31, 2018. Veterans who were aged ≥ 18 years and received ≥ 2 injections of either risperidone microspheres or paliperidone palmitate during the study period were included. Veterans were excluded if they had received < 2 doses of either LAIA, received the LAIA outside of the review period, were nonadherent to risperidone crossover if they received risperidone microspheres, or transferred their care to another facility. At VALLHS, LAIA injections are administered by a nurse, and veterans must travel to the facility to receive the injections.

Extracted patient chart elements included participant demographics; diagnoses; comorbid alcohol, nicotine, opioid, or other substance use; duration on LAIA; psychiatric hospitalizations pre- and postinitiation of the LAIA; medication adherence; and medication discontinuation based on clinician documentation and clinic orders (Table 1).

Data Analysis

Patient demographics were analyzed using descriptive statistics and experimental comparisons between the risperidone microspheres and paliperidone palmitate groups to assess baseline differences between groups. Psychiatric hospitalizations pre- and post-LAIA were analyzed with parallel group (between veterans–independent groups) and pre-post (within veterans–dependent groups) designs. Index hospitalizations were examined for a period equivalent to the length of time veterans were on the LAIA. Psychiatric rehospitalization rates were analyzed for patients who had index hospitalizations and were rehospitalized for any period when they were receiving the LAIA. Incidences of pre- and post-LAIA hospitalizations were calculated in 100 person-years.

Parallel-group analysis was analyzed using the χ² and Mann-Whitney U tests. Pre-post analyses were analyzed using the Wilcoxon rank sum test. P was set at < .05 for statistical significance.

Results

We screened 111 veterans, and 97 were included in this study (risperidone microspheres, 44; paliperidone palmitate, 53). Mean (SD) age was 46 (13.8) years, 92% were male, 38% were White, 94% were diagnosed with schizophrenia or schizoaffective disorder, and 11% were homeless. Substance use was documented as 52% for nicotine products, 40% for alcohol, 31% for cannabis, 27% for methamphetamine, 7% for cocaine, and 3% for opioids. Cannabis, methamphetamine, cocaine, and opioid use were based on clinician documentation and listed as active diagnoses at the time of LAIA initiation. Statistical significance was found in index hospitalizations P = .009) and history of cocaine use disorder (6.8% vs 7.5%, P < .001).

Veterans administered risperidone microspheres had fewer mean (SD) post-LAIA hospitalizations (0.4 [1.0] vs 0.9 [1.5]; P = .02) and were less likely to be rehospitalized (22.7% vs 47.2%, P = .01) compared with paliperidone palmitate. However, veterans taking risperidone microspheres had a shorter mean (SD) treatment duration (41.6 [40.2] vs 58.2 [45.7] weeks, P = .04) compared with paliperidone palmitate, mainly because patients switched to a different LAIA or oral antipsychotic. No differences were detected in nonadherence and discontinuation between risperidone microspheres and paliperidone palmitate. All veterans in the risperidone microspheres group adhered to oral risperidone crossover with an average 87.8% days covered (Table 2).

Discussion

The main finding of this study was that initiation of LAIAs significantly reduced hospitalizations. Veterans taking risperidone microspheres had higher index hospitalizations and lower posttreatment hospitalizations compared with paliperidone palmitate. We found that patients initiated on risperidone microspheres had more hospitalizations before use of a LAIA than those initiated on paliperidone palmitate. Risperidone microspheres reduced the number of hospitalization post-LAIA significantly more than paliperidone palmitate. We also found that veterans taking risperidone microspheres were on the medication for less mean (SD) time than those on paliperidone palmitate (41.6 [40.2] vs 58.2 [45.7] weeks; P = .04).

To our knowledge, this is one of the few studies that compared outcomes of psychiatric hospitalizations, medication adherence, and treatment discontinuation between risperidone microspheres and paliperidone palmitate, specifically in a veteran population.^16-19 Limosin and colleagues aimed to compare length of stay during the initial hospitalization, rehospitalization risk, and treatment duration between risperidone microspheres and paliperidone palmitate in patients with schizophrenia.¹⁶ These researchers detected no differences in initial hospitalization duration and time to rehospitalization between risperidone microspheres and paliperidone palmitate.¹⁶ The study revealed a more favorable trend in time to discontinuation for paliperidone palmitate, but switching between LAIAs might have confounded the data.¹⁶ The authors note that their study lacked power, and patients on paliperidone palmitate had significantly more nonpsychiatric comorbidities.¹⁶ Joshi and colleagues looked at adherence, medication discontinuation, hospitalization rates, emergency department visits, and hospitalization costs between risperidone microspheres and paliperidone palmitate in patients identified in Truven MarketScan Commercial, Medicare Supplemental, and Medicaid Multi-State insurance databases.¹⁷ The authors found paliperidone palmitate to be superior in all objectives with better adherence, lower discontinuation rates, less likelihood of hospitalization, fewer emergency department visits, and lower hospitalization costs compared with risperidone microspheres.¹⁷ Korell and colleagues aimed to establish reference ranges for plasma concentrations of risperidone and paliperidone among adherent patients.¹⁸

The results in our study are somewhat unexpected in part because of the close relationship between risperidone and paliperidone. Risperidone is converted to paliperidone (9-OH-risperidone) via hepatic cytochrome P450 2D6. Although the molecules do not have identical pharmacologic profiles, it is accepted that they are similar enough that risperidone can establish oral tolerability when transitioning therapy to paliperidone palmitate and vice versa.²⁴ Although the active moiety in risperidone microspheres and paliperidone palmitate is similar, the dosing interval for risperidone microspheres is 2 weeks compared with 4 weeks with paliperidone palmitate. One potential explanation as to why veterans started on risperidone microspheres experienced better outcomes is because they had twice as many office visits with the health care team. Facility procedures dictate veterans receive the LAIA at an on-site clinic. During the visits, a licensed vocational nurse administers the injection and monitors the patient for 15 to 30 minutes afterward.

Despite new LAIAs coming to market, high-quality data examining potential differences in treatment outcomes among agents are limited. This is problematic for clinicians who want to optimize care by understanding how administration schedules or other aspects of LAIA use could modify treatment outcomes. Our results suggest that an advantage might exist in selecting an agent with a more frequent administration schedule, at least initially. This could allow for close monitoring and regular therapeutic contact, which could improve short-term outcomes. This conclusion is supported by meta-analyses, randomized controlled trials, and conceptual articles conducted by Wehring and colleagues, Berwaerts and colleagues, and Parellada and colleagues, respectively, who examined patients on different LAIAs and contact with health care professionals as part of their research.^26-28 These researchers concluded that patients who had regular contact with a health care professional had better outcomes when initiated on a LAIA.^26-28

Limitations

There are several limitations in this study. Retrospective and observational methods introduce risks of bias and confounding variables. Sample size might have limited statistical power to detect differences. Veterans might have had undocumented pre- or posthospitalizations at other institutions, which was not accounted for and lack of rehospitalization is not conclusive of a positive outcome. Institutions could improve on our study and help to fill gaps in comparative data by conducting larger analyses over longer periods and including more LAIA agents.

Conclusions

Although veterans that were administered risperidone microspheres had a shorter treatment duration, they were less likely to be rehospitalized, had a fewer mean number of post-LAIA hospitalizations, and had a larger difference in incidence in 100 person-years compared with veterans on paliperidone palmitate. Nonadherence and discontinuation rates were comparable between risperidone microspheres and paliperidone palmitate. Future studies could aim to further clarify differences in outcomes among agents or administration schedules.

Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.

For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”

Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.

And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.

In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.        

The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.

Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.

“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
 

Physician-driven success  

Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.

Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.

“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”

Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.

“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”

Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.

“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”

Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.

Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”

Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.

In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
 

Adapting to benefit children and parents

Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime. 

“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.

“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”

Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.

“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.

“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”

A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.

The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”

As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.

“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”

“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”

A version of this article first appeared on Medscape.com.

Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.

For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”

Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.

And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.

In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.        

The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.

Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.

“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
 

Physician-driven success  

Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.

Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.

“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”

Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.

“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”

Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.

“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”

Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.

Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”

Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.

In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
 

Adapting to benefit children and parents

Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime. 

“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.

“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”

Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.

“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.

“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”

A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.

The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”

As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.

“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”

“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”

A version of this article first appeared on Medscape.com.

Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.

For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”

Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.

And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.

In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.        

The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.

Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.

“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
 

Physician-driven success  

Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.

Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.

“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”

Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.

“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”

Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.

“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”

Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.

Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”

Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.

In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
 

Adapting to benefit children and parents

Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime. 

“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.

“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”

Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.

“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.

“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”

A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.

The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”

As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.

“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”

“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”

A version of this article first appeared on Medscape.com.

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

A version of this article first appeared on Medscape.com.

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

A version of this article first appeared on Medscape.com.

Motivated, calm, and high-functioning. On the surface, you are the epitome of success. You arrive at work early. You are driven, meet all deadlines and, in fact, excel at tasks. Not only are you successful in your work, but also you appear well put-together – not a single hair out of place. You have a busy social life, always smiling, laughing, or generally in an uplifting mood. On the surface, you have everything together. 

Inside, you’re drowning. You’re in constant survival mode – always overthinking, ruminating, and fearful. Your need for self-preservation is in overdrive. You use your anxiety and fear as motivation. You are a people pleaser, need constant reassurance, and are unable to enjoy the present moment. You have an inability to say no regardless of your overloaded schedule. You are mentally and physically fatigued and overworked beyond the brink of exhaustion. You need to take time off but can’t bring yourself to do so. Others wouldn’t see you in this light because you always appear to be doing well.

The portraits I’ve painted here sound like two different people, but in fact are representative of one. High-functioning anxiety, while not a formal health diagnosis, is a term that broadly encapsulates individuals who experience anxiety but also function well in their day-to-day lives. On the surface, individuals with high-functioning anxiety appear to be “perfect” but in actuality are under constant stress and anxiety in fear of disappointing others. They are perceived as overachievers, but this perception fails to recognize and acknowledge the mental health toll required to achieve at such a high level.

I came across this concept when a friend sent me a post on social media. It was a completely new but oddly familiar concept when I first read about high-functioning anxiety. In fact, I related to this concept almost immediately based on interactions with friends and colleagues, and their recollection of stressors over the years in high-stress, high-functioning environments. 

In addition to personal interactions, I’ve seen anxiety and mental health at large become more “normalized” on various platforms (e.g., Instagram, TikTok) over the years. Interestingly, normalizing these concepts could be beneficial. For example, they increase awareness, encourage conversations (e.g., creating communities), and minimize the barriers toward understanding and respecting individuals who experience high-functioning anxiety. However, social media also has the potential to be harmful (e.g., “humorizing” the concept or turning it into memes, diminishing the experience).

However, the question that nagged at my mind even further was: What reasons are there, if any, for why high-functioning anxiety is not recognized as a formal diagnosis? Is this concept too new? Difficult to diagnose? Anecdotal evidence seems to suggest that high-functioning anxiety is debilitating and impairs one’s quality of life. There appears to be a need to formally recognize this subtype of anxiety and invest more time and research. Increasing the sphere of knowledge may bring more good than harm, as a way to let others know that it’s okay.

Ms. Lui is an MSc candidate at the University of Toronto and is with the mood disorders psychopharmacology unit, Toronto Western Hospital, University Health Network, also in Toronto. She reported receiving income from Braxia Scientific.

A version of this article first appeared on Medscape.com.

In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention. 

Marija Jovovic/Getty Images

Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.

These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.

Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”

When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix. 

And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.

At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment. 

Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
 

Defining mindfulness

“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment. 

Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”

Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit. 

When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”

Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.

“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
 

Making time for mindfulness

Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people. 

Mindfulness training requires that physicians use what they already have so little of: time.

Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible. 

For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”

In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress. 

Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily. 
 

An integrated strategy

Dr. Wener acknowledges that meditation is not the panacea for everyone’s burnout, which data support. In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms. 

“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.

Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training. 

Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”

Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution. 

“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”

A version of this article first appeared on Medscape.com.

In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention. 

Marija Jovovic/Getty Images

Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.

These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.

Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”

When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix. 

And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.

At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment. 

Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
 

Defining mindfulness

“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment. 

Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”

Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit. 

When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”

Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.

“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
 

Making time for mindfulness

Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people. 

Mindfulness training requires that physicians use what they already have so little of: time.

Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible. 

For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”

In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress. 

Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily. 
 

An integrated strategy

Dr. Wener acknowledges that meditation is not the panacea for everyone’s burnout, which data support. In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms. 

“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.

Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training. 

Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”

Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution. 

“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”

A version of this article first appeared on Medscape.com.

In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention. 

Marija Jovovic/Getty Images

Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.

These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.

Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”

When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix. 

And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.

At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment. 

Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
 

Defining mindfulness

“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment. 

Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”

Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit. 

When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”

Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.

“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
 

Making time for mindfulness

Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people. 

Mindfulness training requires that physicians use what they already have so little of: time.

Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible. 

For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”

In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress. 

Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily. 
 

An integrated strategy

Dr. Wener acknowledges that meditation is not the panacea for everyone’s burnout, which data support. In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms. 

“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.

Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training. 

Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”

Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution. 

“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”

A version of this article first appeared on Medscape.com.

As pediatricians, we are acutely aware of the increase in depression in our teen patients. Lifetime prevalence is now approaching 20%, and we are doing our best to help.

The Guidelines for Adolescent Depression in Primary Care (GLAD-PC, 2018) has advice on screening and primary care provider (PCP) management, verifying our role in care. But GLAD-PC also advises “referral to a mental health specialist” in patient scenarios we see multiple times per week. Even when patients are willing and able to go, mental health specialists are in short supply or have months-long waiting lists. What should we do to help the more severely depressed adolescent when immediate referral is not possible? What should we expect of specialist care for what is called treatment-resistant or treatment-refractory depression (TRD)?

To know what to do for a youth with TRD, first you need to know what constitutes an adequate trial of treatment. After diagnosis of major depressive disorder (MDD) from a validated screening tool or an interview based on DSM-5 criteria and an appropriate assessment (as described in GLAD-PC), patients and parents need education on symptoms, course, prognosis including suicide risk, and treatment options. Known TRD risk factors, besides longer or greater depression severity, anhedonia, and poor global functioning, can benefit from being specifically addressed: trauma, bullying, comorbid anxiety or substance use, subsyndromal mania, insomnia, hypothyroidism, nutritional deficiencies from eating disorders, certain genetic variants, LGBTQ identification, family conflict, and parental depression. Screening and assessment for suicidal ideation/attempts is needed initially and in follow-up as MDD increases risk of suicide 30 times.

PCPs can manage mild depression with regular visits every 1-2 weeks for active support for 6-8 weeks. Advise all depressed youth on healthy eating, adequate sleep and exercise, pleasurable activities, and refraining from substance use. With a full response (50%+ reduction in symptom score from baseline), monthly monitoring for symptoms, suicidality, and stressors (phone/televisits suffice) should continue for 6-24 months as half recur. Monitoring with ratings by both youth and parent are recommended and may be required by insurers. Scores below cutoff suggest “remission,” although functioning must be considered. Youth report symptoms best but parents may better report improved functioning and affect that can precede symptom reduction.

If there is no initial response (< 25% decrease in symptom score) or a partial response (25%-49% decrease), PCPs should begin treatment as for moderate depression with either a selective serotonin reuptake inhibitor (SSRI) or psychotherapy. Use of both has the best evidence; cognitive behavior therapy (CBT) and interpersonal psychotherapy for adolescents are equally effective.

Side effects from SSRIs are almost universal with GI upset, headaches, and sexual dysfunction most common, but activation (increased agitation or irritability) may occur. Educate patients about these and encourage tolerating them as they tend to subside in weeks, allowing continuation of these most effective medicines. Activation rarely indicates true mania, which would require stopping and referral.

Moderate depression with only comorbid anxiety may be addressed by PCPs with problem-focused supportive counseling and SSRIs, but mental health consultation or referral also are appropriate. Fluoxetine starting at 5-10 mg/day has best evidence and Food and Drug Administration approval for MDD from age 8. Starting at a higher dose may increase risk of suicidal ideation. Alternatively, escitalopram is FDA approved for MDD at age 12 starting at 10 mg/day, although meta-analyses do not distinguish effectiveness within the SSRI class. Although benefit usually appears within 2 weeks, a trial of at least 4 weeks should be used to assess effect.

If after 4 weeks, the SSRI is tolerated but has little or no response, reassess the diagnosis, try a different SSRI, e.g. sertraline, and add CBT (combined SSRI+CBT has an advantage). To switch SSRIs, reduce the first every 1-2 weeks (by 10-20 mg for fluoxetine; 5-10 for escitalopram) to reduce side effects. If overlapping, the replacement SSRI may start midway in the wean at low dose with patients educated about serotonin syndrome. If instead there was a partial response to the initial SSRI, progressively increase the dose (by 10 mg for fluoxetine or 5 mg for escitalopram monthly) as indicated by symptom change up to the maximum (60-80 mg fluoxetine or 20 mg escitalopram), if needed, and maintain for another 4 weeks. Alternatively, or in addition, start psychotherapy or ask to change current therapy, as therapy focus makes a difference in effect. Initial CBT focus on anxiety acts fastest when anxiety is comorbid.

Once a regimen produces a response, maintain it for 16-20 weeks, the longer for more severe depression. Although three-fourths of mildly to moderately depressed youth are late responders, emerging near 6 weeks, a rapid initial response is associated with better outcome. The recommended 8 weeks on a final tolerated dose constituting an adequate trial before changing may be shortened to 6 weeks in severe unremitting cases. Youth not remitting by 12 weeks should be offered alternative treatment. Referral is recommended for moderately severe depression with comorbidity or severe depression but also for unresponsive moderate depression or by family or clinician preference.

Treatment-resistant depression is defined as “clinically impairing depression symptoms despite an adequate trial of an evidence-based psychotherapy and an antidepressant with grade A evidence (fluoxetine, escitalopram, or sertraline),” sequentially or together; treatment-refractory depression comprises the above with failure on at least two antidepressants, with at least one being grade A. Unfortunately, TRD occurs in 30%-40% of children and remission is only 30%. Low adherence based on pill counts (> 30% missed) or with therapy (fewer than nine visits) should be considered in treatment failures.

With manageable factors addressed, the next step for TRD is treatment augmentation. The best evidence-based augmentation for TRD is CBT; 55% of those receiving CBT responded within 12 weeks. TRD augmentations and interventions with evidence in adults have either no evidence of effect in children (SNRIs, lithium), no randomized controlled trials, or support only from small suggestive studies, e.g., antipsychotics, 16 g/day omega-3 fatty acid supplementation, folic acid supplementation, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or ketamine. Prompt referral to a child psychiatrist is essential for youth classified as TRD as earlier more aggressive treatment may avoid the long-term morbidity of chronic depression.

Fortunately, a meta-analysis of studies showed that PCP medication management visits with monitoring could improve outcomes, even for TRD.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Reference

Dwyer J et al. Annual research review: Defining and treating pediatric treatment-resistant depression. J Child Psychol Psychiatry. 2020 March;61(3):312-32.

As pediatricians, we are acutely aware of the increase in depression in our teen patients. Lifetime prevalence is now approaching 20%, and we are doing our best to help.

The Guidelines for Adolescent Depression in Primary Care (GLAD-PC, 2018) has advice on screening and primary care provider (PCP) management, verifying our role in care. But GLAD-PC also advises “referral to a mental health specialist” in patient scenarios we see multiple times per week. Even when patients are willing and able to go, mental health specialists are in short supply or have months-long waiting lists. What should we do to help the more severely depressed adolescent when immediate referral is not possible? What should we expect of specialist care for what is called treatment-resistant or treatment-refractory depression (TRD)?

To know what to do for a youth with TRD, first you need to know what constitutes an adequate trial of treatment. After diagnosis of major depressive disorder (MDD) from a validated screening tool or an interview based on DSM-5 criteria and an appropriate assessment (as described in GLAD-PC), patients and parents need education on symptoms, course, prognosis including suicide risk, and treatment options. Known TRD risk factors, besides longer or greater depression severity, anhedonia, and poor global functioning, can benefit from being specifically addressed: trauma, bullying, comorbid anxiety or substance use, subsyndromal mania, insomnia, hypothyroidism, nutritional deficiencies from eating disorders, certain genetic variants, LGBTQ identification, family conflict, and parental depression. Screening and assessment for suicidal ideation/attempts is needed initially and in follow-up as MDD increases risk of suicide 30 times.

PCPs can manage mild depression with regular visits every 1-2 weeks for active support for 6-8 weeks. Advise all depressed youth on healthy eating, adequate sleep and exercise, pleasurable activities, and refraining from substance use. With a full response (50%+ reduction in symptom score from baseline), monthly monitoring for symptoms, suicidality, and stressors (phone/televisits suffice) should continue for 6-24 months as half recur. Monitoring with ratings by both youth and parent are recommended and may be required by insurers. Scores below cutoff suggest “remission,” although functioning must be considered. Youth report symptoms best but parents may better report improved functioning and affect that can precede symptom reduction.

If there is no initial response (< 25% decrease in symptom score) or a partial response (25%-49% decrease), PCPs should begin treatment as for moderate depression with either a selective serotonin reuptake inhibitor (SSRI) or psychotherapy. Use of both has the best evidence; cognitive behavior therapy (CBT) and interpersonal psychotherapy for adolescents are equally effective.

Side effects from SSRIs are almost universal with GI upset, headaches, and sexual dysfunction most common, but activation (increased agitation or irritability) may occur. Educate patients about these and encourage tolerating them as they tend to subside in weeks, allowing continuation of these most effective medicines. Activation rarely indicates true mania, which would require stopping and referral.

Moderate depression with only comorbid anxiety may be addressed by PCPs with problem-focused supportive counseling and SSRIs, but mental health consultation or referral also are appropriate. Fluoxetine starting at 5-10 mg/day has best evidence and Food and Drug Administration approval for MDD from age 8. Starting at a higher dose may increase risk of suicidal ideation. Alternatively, escitalopram is FDA approved for MDD at age 12 starting at 10 mg/day, although meta-analyses do not distinguish effectiveness within the SSRI class. Although benefit usually appears within 2 weeks, a trial of at least 4 weeks should be used to assess effect.

If after 4 weeks, the SSRI is tolerated but has little or no response, reassess the diagnosis, try a different SSRI, e.g. sertraline, and add CBT (combined SSRI+CBT has an advantage). To switch SSRIs, reduce the first every 1-2 weeks (by 10-20 mg for fluoxetine; 5-10 for escitalopram) to reduce side effects. If overlapping, the replacement SSRI may start midway in the wean at low dose with patients educated about serotonin syndrome. If instead there was a partial response to the initial SSRI, progressively increase the dose (by 10 mg for fluoxetine or 5 mg for escitalopram monthly) as indicated by symptom change up to the maximum (60-80 mg fluoxetine or 20 mg escitalopram), if needed, and maintain for another 4 weeks. Alternatively, or in addition, start psychotherapy or ask to change current therapy, as therapy focus makes a difference in effect. Initial CBT focus on anxiety acts fastest when anxiety is comorbid.

Once a regimen produces a response, maintain it for 16-20 weeks, the longer for more severe depression. Although three-fourths of mildly to moderately depressed youth are late responders, emerging near 6 weeks, a rapid initial response is associated with better outcome. The recommended 8 weeks on a final tolerated dose constituting an adequate trial before changing may be shortened to 6 weeks in severe unremitting cases. Youth not remitting by 12 weeks should be offered alternative treatment. Referral is recommended for moderately severe depression with comorbidity or severe depression but also for unresponsive moderate depression or by family or clinician preference.

Treatment-resistant depression is defined as “clinically impairing depression symptoms despite an adequate trial of an evidence-based psychotherapy and an antidepressant with grade A evidence (fluoxetine, escitalopram, or sertraline),” sequentially or together; treatment-refractory depression comprises the above with failure on at least two antidepressants, with at least one being grade A. Unfortunately, TRD occurs in 30%-40% of children and remission is only 30%. Low adherence based on pill counts (> 30% missed) or with therapy (fewer than nine visits) should be considered in treatment failures.

With manageable factors addressed, the next step for TRD is treatment augmentation. The best evidence-based augmentation for TRD is CBT; 55% of those receiving CBT responded within 12 weeks. TRD augmentations and interventions with evidence in adults have either no evidence of effect in children (SNRIs, lithium), no randomized controlled trials, or support only from small suggestive studies, e.g., antipsychotics, 16 g/day omega-3 fatty acid supplementation, folic acid supplementation, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or ketamine. Prompt referral to a child psychiatrist is essential for youth classified as TRD as earlier more aggressive treatment may avoid the long-term morbidity of chronic depression.

Fortunately, a meta-analysis of studies showed that PCP medication management visits with monitoring could improve outcomes, even for TRD.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Reference

Dwyer J et al. Annual research review: Defining and treating pediatric treatment-resistant depression. J Child Psychol Psychiatry. 2020 March;61(3):312-32.

As pediatricians, we are acutely aware of the increase in depression in our teen patients. Lifetime prevalence is now approaching 20%, and we are doing our best to help.

The Guidelines for Adolescent Depression in Primary Care (GLAD-PC, 2018) has advice on screening and primary care provider (PCP) management, verifying our role in care. But GLAD-PC also advises “referral to a mental health specialist” in patient scenarios we see multiple times per week. Even when patients are willing and able to go, mental health specialists are in short supply or have months-long waiting lists. What should we do to help the more severely depressed adolescent when immediate referral is not possible? What should we expect of specialist care for what is called treatment-resistant or treatment-refractory depression (TRD)?

To know what to do for a youth with TRD, first you need to know what constitutes an adequate trial of treatment. After diagnosis of major depressive disorder (MDD) from a validated screening tool or an interview based on DSM-5 criteria and an appropriate assessment (as described in GLAD-PC), patients and parents need education on symptoms, course, prognosis including suicide risk, and treatment options. Known TRD risk factors, besides longer or greater depression severity, anhedonia, and poor global functioning, can benefit from being specifically addressed: trauma, bullying, comorbid anxiety or substance use, subsyndromal mania, insomnia, hypothyroidism, nutritional deficiencies from eating disorders, certain genetic variants, LGBTQ identification, family conflict, and parental depression. Screening and assessment for suicidal ideation/attempts is needed initially and in follow-up as MDD increases risk of suicide 30 times.

PCPs can manage mild depression with regular visits every 1-2 weeks for active support for 6-8 weeks. Advise all depressed youth on healthy eating, adequate sleep and exercise, pleasurable activities, and refraining from substance use. With a full response (50%+ reduction in symptom score from baseline), monthly monitoring for symptoms, suicidality, and stressors (phone/televisits suffice) should continue for 6-24 months as half recur. Monitoring with ratings by both youth and parent are recommended and may be required by insurers. Scores below cutoff suggest “remission,” although functioning must be considered. Youth report symptoms best but parents may better report improved functioning and affect that can precede symptom reduction.

If there is no initial response (< 25% decrease in symptom score) or a partial response (25%-49% decrease), PCPs should begin treatment as for moderate depression with either a selective serotonin reuptake inhibitor (SSRI) or psychotherapy. Use of both has the best evidence; cognitive behavior therapy (CBT) and interpersonal psychotherapy for adolescents are equally effective.

Side effects from SSRIs are almost universal with GI upset, headaches, and sexual dysfunction most common, but activation (increased agitation or irritability) may occur. Educate patients about these and encourage tolerating them as they tend to subside in weeks, allowing continuation of these most effective medicines. Activation rarely indicates true mania, which would require stopping and referral.

Moderate depression with only comorbid anxiety may be addressed by PCPs with problem-focused supportive counseling and SSRIs, but mental health consultation or referral also are appropriate. Fluoxetine starting at 5-10 mg/day has best evidence and Food and Drug Administration approval for MDD from age 8. Starting at a higher dose may increase risk of suicidal ideation. Alternatively, escitalopram is FDA approved for MDD at age 12 starting at 10 mg/day, although meta-analyses do not distinguish effectiveness within the SSRI class. Although benefit usually appears within 2 weeks, a trial of at least 4 weeks should be used to assess effect.

If after 4 weeks, the SSRI is tolerated but has little or no response, reassess the diagnosis, try a different SSRI, e.g. sertraline, and add CBT (combined SSRI+CBT has an advantage). To switch SSRIs, reduce the first every 1-2 weeks (by 10-20 mg for fluoxetine; 5-10 for escitalopram) to reduce side effects. If overlapping, the replacement SSRI may start midway in the wean at low dose with patients educated about serotonin syndrome. If instead there was a partial response to the initial SSRI, progressively increase the dose (by 10 mg for fluoxetine or 5 mg for escitalopram monthly) as indicated by symptom change up to the maximum (60-80 mg fluoxetine or 20 mg escitalopram), if needed, and maintain for another 4 weeks. Alternatively, or in addition, start psychotherapy or ask to change current therapy, as therapy focus makes a difference in effect. Initial CBT focus on anxiety acts fastest when anxiety is comorbid.

Once a regimen produces a response, maintain it for 16-20 weeks, the longer for more severe depression. Although three-fourths of mildly to moderately depressed youth are late responders, emerging near 6 weeks, a rapid initial response is associated with better outcome. The recommended 8 weeks on a final tolerated dose constituting an adequate trial before changing may be shortened to 6 weeks in severe unremitting cases. Youth not remitting by 12 weeks should be offered alternative treatment. Referral is recommended for moderately severe depression with comorbidity or severe depression but also for unresponsive moderate depression or by family or clinician preference.

Treatment-resistant depression is defined as “clinically impairing depression symptoms despite an adequate trial of an evidence-based psychotherapy and an antidepressant with grade A evidence (fluoxetine, escitalopram, or sertraline),” sequentially or together; treatment-refractory depression comprises the above with failure on at least two antidepressants, with at least one being grade A. Unfortunately, TRD occurs in 30%-40% of children and remission is only 30%. Low adherence based on pill counts (> 30% missed) or with therapy (fewer than nine visits) should be considered in treatment failures.

With manageable factors addressed, the next step for TRD is treatment augmentation. The best evidence-based augmentation for TRD is CBT; 55% of those receiving CBT responded within 12 weeks. TRD augmentations and interventions with evidence in adults have either no evidence of effect in children (SNRIs, lithium), no randomized controlled trials, or support only from small suggestive studies, e.g., antipsychotics, 16 g/day omega-3 fatty acid supplementation, folic acid supplementation, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or ketamine. Prompt referral to a child psychiatrist is essential for youth classified as TRD as earlier more aggressive treatment may avoid the long-term morbidity of chronic depression.

Fortunately, a meta-analysis of studies showed that PCP medication management visits with monitoring could improve outcomes, even for TRD.
 

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.

Reference

Dwyer J et al. Annual research review: Defining and treating pediatric treatment-resistant depression. J Child Psychol Psychiatry. 2020 March;61(3):312-32.