Sleep Disturbances Found to Predict Suicide Ideation in High-Risk Youth

Disturbed sleep may be a short-term indicator of increased suicidal ideation in young adults at high risk of suicide, according to a study published this week in the Journal of Clinical Psychiatry.

“Sleep disturbances stand apart from other risk factors because they are visible as a warning sign, yet non-stigmatizing and highly treatable … using brief, fast-acting interventions,” said lead author Rebecca Bernert, Ph.D., an assistant professor of psychiatry and behavioral sciences at Stanford University, in a press release. “That is why we believe they may represent an important treatment target in suicide prevention.”

Bernert and colleagues recruited 50 adults aged 18 to 23 who reported at least one past suicide attempt and/or recent suicide ideation from a university undergraduate research pool for the three-week study. At the start of the study, and 7 and 21 days later, participants answered questionnaires to measure the severity of their suicidal symptoms, insomnia, nightmares, depression, and alcohol use.

The researchers assessed participants’ sleep objectively for one week, during which participants wore watch-like devices containing an accelerometer to measure their wrist movements while asleep or trying to sleep. (The device had been validated as an accurate way to distinguish sleep-wake patterns and generate a variety of sleep metrics.)

Of the 50 participants included in the trial, 48 (96%) had at least one prior suicide attempt. Mean actigraphy values revealed objectively disturbed sleep parameters in these patients: 39 (78%) exhibited sleep patterns indicating clinically significant insomnia and 18 (36%) showed signs of nightmares.

The researchers found that that actigraphic and self-reported sleep disturbances (insomnia, nightmares, and sleep-onset variability) predicted acute suicidal ideation symptom changes at 7- and 21-day follow-ups, even when controlled for the severity of participants’ depression, substance use, and the severity of their suicidal symptoms at the start of the study. Falling asleep at very different times each night and waking at different times in the morning was especially predictive of an increase in suicidal symptoms at the 7- and 21-day marks. Participants with substantial variation in falling asleep times also reported more insomnia and nightmares, which independently predicted more suicidal behaviors, according to the study.

“To our knowledge, this is the first longitudinal report indicating that objectively and subjectively measured sleep disturbance confers risk for suicidal ideation independent of depression severity,” the study authors wrote. “Given the ease of sleep disturbance assessment and treatment, and its unique visibility as a warning sign, we propose poor sleep as a potential biomarker and therapeutic target for suicide prevention.”

For related information, see the Psychiatric News article “Sleep Experts Issue Recommendations for Children and Adolescent Sleep.”

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Wider Use of ECT May Lead to Lower Readmission Rates, Study Finds

Patients with severe affective disorders who receive inpatient treatment with electroconvulsive therapy (ECT) may be less likely to be readmitted for psychiatric care 30 days following discharge than those who do not receive this treatment, reports a study published Wednesday in JAMA Psychiatry. The findings suggest that broader use of ECT may lead to fewer readmissions of these patients.

“Previous studies have found that treatment with ECT is associated with remission from depressive disorders and reductions in mortality in individuals with MDD [major depressive disorder] and posttraumatic stress disorder,” lead author Eric Slade, Ph.D., of the University of Maryland School of Medicine and colleagues wrote. “The results of the present study add evidence that wider availability of ECT may result in up to 46% fewer inpatient readmissions within 30 days of discharge among individuals with severe affective disorders.”

For the study, Slade and colleagues relied on information contained in the Health Care Utilization Project’s State Inpatient Databases (SID) from general hospitals in the following nine states: Arizona, Arkansas, California, Florida, Nevada, New York, North Carolina, Utah, and Washington. (The rate of inpatient readmission within 30 days following discharge from psychiatric inpatient care is a metric commonly used to evaluate mental health systems.) While SIDs are available for most states, only the nine states included in the study had complete data on patient readmissions.

Among the 162,691 inpatients with a principal diagnosis of MDD, bipolar disorder, or schizoaffective disorder included in the analysis, 2,486 (1.5%) underwent ECT during their index admission. Compared with inpatients being treated for mental illness, those who received ECT were older, more likely to be female, and/or white non-Hispanic; have MDD diagnoses rather than either bipolar disorder or schizoaffective disorder; have private or Medicare insurance coverage; and were more likely to be seen in small, urban hospitals or nonurban hospitals.

Administration of ECT was associated with a reduced 30-day readmission risk among psychiatric inpatients with severe affective disorders from an estimated 12.3% among individuals not administered ECT to 6.6% among individuals administered ECT (risk ratio=0.54)—a 46% reduction in 30-day readmission risk. “The effect of ECT on 30-day readmission risk did not differ significantly by age or race/ethnicity but was relatively larger among men than women and among individuals with bipolar disorder and schizoaffective disorder than among those with MDD,” the authors wrote.

“The findings of Slade et al. should be interpreted in the context of a large and diverse body of evidence regarding ECT efficacy,” Harold Sackeim, Ph.D., a professor of psychiatry at Columbia University, wrote in a related editorial. “This includes randomized trials comparing ECT with sham treatment (anesthesia alone), randomized comparisons of the effect of ECT technical factors on clinical outcomes, randomized comparisons with pharmacotherapy, and large, prospective patient series in research and community settings. The evidence indicating that ECT is effective in the treatment of mood disorders is diverse, long-standing, and incontrovertible. In both the short term and long term, it appears to exert greater benefit than pharmacological alternatives.”

For related information, see the Psychiatric News article “Older Patients With Depression May Benefit From ECT, Medication Combo.”

More Than Half of All U.S. Opioid Prescriptions Go to Patients With Mental Illness, Study Suggests

An estimated 16% of people in the United States have a diagnosed mental illness, yet this population receives over half of all prescribed opioids, reports a study scheduled to appear in the July issue of the Journal of the American Board of Family Medicine.

“There exists a complex interaction of factors related to the patient, provider, and medical and social conditions that ultimately results in the decision to prescribe an opioid,” wrote study authors Matthew Davis, Ph.D., M.P.H., of the University of Michigan and colleagues.

“Our findings … suggest that there may be additional patient- and provider-related factors specific to those with mental illness that increase the likelihood of receiving prescription opioids,” they continued. “Such a relationship is particularly concerning because mental illness is also a prominent risk factor for overdose and other adverse opioid-related outcomes.”

Davis and colleagues performed their study using data from the 2011 and 2013 results of the Medical Expenditure Panel Survey, a national survey conducted by the Agency for Healthcare Research and Quality that gathers extensive information on health care use, including prescription medications, and expenditures.

They found that approximately 19% of adults with a mental health disorder were opioid users (defined as fulfilling at least two opioid prescriptions in a calendar year), compared with only 5% of adults without a mental health disorder. After adjusting for sociodemographic and health factors, adults with mental health disorders had more than twice the odds of being an opioid user (odds ratio=2.08). The higher risk of opioid use in adults with mental illness was evident across a range of pain types, such as cancer pain or muscular pain.

When extrapolating their data to the general population, Davis and colleagues estimated that 60 million of the approximately 115 million opioid prescriptions distributed each year (51.4%) go to the 38.6 million adults with mental health disorders.

John Renner, M.D., vice chair of APA’s Council on Addiction Psychiatry, commented on the study results. “The overlap between depression and chronic pain is well known. Once patients are given an opioid, they may notice a reduction in pain and an improvement in mood and then may be very resistant to stopping the opioid. Patients may not even be conscious of the improved mood, but they are more likely to try to continue the medication. I do not think that physicians deliberately prescribe an opioid because of the presence of mental illness; data seem to suggest that many primary care physicians aren’t screening for psychiatric symptoms.”

To read more about this topic, see the Psychiatric News article “APA Holds Congressional Briefing on Ending the Opioid Epidemic” and the Psychiatric Services article “Prescriptions Filled Following an Opioid-Related Hospitalization.”

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Millions to Lose Health Coverage Under Senate Health Bill, CBO Predicts

The Senate Republicans' proposal to repeal and replace the Affordable Care Act (ACA) would increase the number of people without health insurance by 15 million in 2018 and 22 million people by 2026, according to a Congressional Budget Office (CBO) analysis released on Monday. APA responded promptly to the news, renewing its call for the U.S. Senate to reject the bill known as the Better Care Reconciliation Act (BCRA).

“The CBO report highlights in stark terms the negative impact of the Senate proposal. The bill would reverse much progress in recent years by rolling back Medicaid expansion, capping the Medicaid program, and allowing states to waive critical essential health benefits,” APA CEO and Medical Director Saul Levin, M.D., M.P.A., said in a press release. “These changes would be particularly devastating to the millions of Americans in need of mental health and substance use treatment.”

The CBO estimates that by 2026, the BCRA would leave 49 million people uninsured, compared with 28 million who would lack insurance that year under current law. Last month, the CBO estimated that the American Health Care Act (AHCA)—which narrowly passed the U.S. House of Representatives in May—would leave some 14 million more people uninsured in 2018 than under the current law and 23 million more by 2026.

The Senate’s health bill would also cut the federal deficit by $321 billion over the decade, according to the CBO. “The largest savings would come from reductions in outlays for Medicaid—spending on the program would decline in 2026 by 26 percent in comparison with what CBO projects under current law—and from changes to the [ACA’s] subsidies for nongroup health insurance,” according to the analysis.

Earlier Monday, APA released a three-page fact sheet summarizing how Medicaid changes could impact access to and the delivery of mental health and substance use disorder treatment services, among other provisions.

“In less than a year after passing comprehensive mental health reform on a bipartisan, bicameral basis, the Senate is now working to pass harmful legislation that will take a significant step backward on the advances to treat those with mental illness and substance use disorders,” Levin continued. “We strongly urge the Senate to reject this deeply flawed proposal.”

The Senate vote on the bill has been delayed due to insufficient support until after the July 4 recess. However, calls and emails expressing concerns are still important as we need to keep the pressure on key senators over the recess.

Your Voice Counts
APA urges you to contact your senators and speak out against the Senate health care reform bill. APA has created a dedicated tool to make it easy for you to voice your opinion via Facebook, Twitter, or phone.

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APA Releases Overview on Impact of Senate Health Bill on Psychiatry

Within a matter of days, the Senate could vote on the Better Care Reconciliation Act (BCRA)—the bill unveiled last week by Senate Republicans to repeal and replace the Affordable Care Act (ACA) and make significant changes to the Medicaid program. 

Tucked within the 142-page discussion draft of BCRA are numerous provisions likely to affect Americans with mental health and substance use disorders. APA’s Government Relations team has created a three-page fact sheet summarizing how BCRA might affect access to and the delivery of mental health and substance use disorder treatment services. 

As described in more detail in the fact sheet, BCRA would cap federal funding for state Medicaid programs on a per-beneficiary basis, phase out the Medicaid expansion made available to states under the ACA, and add administrative costs and burdens to Medicaid. BCRA would also allow states to waive the federal requirements that plans carry certain essential health benefits (EHB)—a change the fact sheet notes “could affect large employer plans, which are only prohibited from imposing annual and lifetime limits on EHB and only required to cap out-of-pocket expenditures for EHB.”

“Eliminating requirements for coverage of key benefits, including mental health and substance use disorders and other patient protections that are part of the Affordable Care Act, will have detrimental impacts for millions,” said APA President-Elect Altha Stewart, M.D., in a press release issued by APA last week. “Mental health is critical to overall health and needs to be equally accessible.”

Additional provisions affecting access to and delivery of evidence-based mental health and substance use disorder treatment services include the following:

• BCRA would create a one-time appropriation of $2 billion in FY 2018 to HHS “to provide grants to States to support substance use disorder treatment and recovery support services for individuals with mental or substance use disorders.” This amount is much less than was offered in the House version of the bill, known as the American Health Care Act (H.R. 1628), which passed the House on May 4.
• BCRA would repeal the Prevention and Public Health Fund, which is a significant source of funding for programs administered by the Substance Abuse and Mental Health Services Administration. 
• States may include inpatient psychiatric services as an optional benefit in their Medicaid plans for individuals aged 21 to 65. The bill also provides a lower match for such services (50 percent) furnished on or after October 1, 2018.

“The Senate proposal represents a significant move in the wrong direction, resulting in fewer people having access to insurance, fewer patient protections, and less coverage for essential behavioral health care,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in the press release. “We urge the Senate to reject this harmful legislation and start again on a health care bill that puts patients first.” 

The House version of the bill, according to the Congressional Budget Office (CBO), would leave some 14 million more Americans uninsured next year than under the current law and 23 million more uninsured by 2026. The Senate bill awaits CBO analysis.

Your Voice Counts
APA urges you to contact your senators and speak out against the Senate health care reform bill released today. APA has created a dedicated tool to make it easy for you to voice your opinion via Facebook, Twitter, or phone.

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Brain Inflammation Linked to OCD, Study Suggests

Brain inflammation appears to be significantly higher in people with obsessive-compulsive disorder (OCD) than those without the condition, according to a study published this week in JAMA Psychiatry. 

“This finding represents one of the biggest breakthroughs in understanding the biology of OCD, and may lead to novel therapeutic treatments,” senior author Jeffrey H. Meyer, M.D., Ph.D., said in a press release. Meyer is the head of the Neurochemical Imaging Program in Mood and Anxiety at the Centre for Addiction and Mental Health (CAMH) in Toronto. 

A new direction for developing treatments for OCD is welcomed because about one-third of patients with OCD do not adequately respond to current medications, such as antidepressants, according to the authors.

Meyer and colleagues recruited 20 people with OCD and 20 age-matched healthy controls for the study. The participants were all in good physical health, were not taking medications, and were between the ages of 19 and 48. None of the participants had a history of autoimmune disease or neurologic illness or injury. Psychiatric disorders and OCD were confirmed using the Structured Clinical Interview of DSM-IV.

All participants underwent a positron emission tomography (PET) scan, using a fluorine dye to measure a marker of microglial activity in six brain regions (dorsal caudate, orbitofrontal cortex, thalamus, ventral striatum, dorsal putamen, and anterior cingulate cortex). Activated microglia (immune cells) are known to trigger neuroinflammation.

The researchers found that in people with OCD, inflammation was on average 32% higher in these regions than among those without the condition. 

“To our knowledge, this is the first study demonstrating inflammation within the neurocircuitry of OCD,” Meyer and colleagues wrote. “Although pharmaceutical development does not traditionally prioritize OCD, neuromodulatory treatments under development for other diseases associated with microglial activation, such as Alzheimer disease, might be repurposed toward OCD.” 

For related information, see the Psychiatric News article “Report Highlights Alternative Treatment Options for OCD.”

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APA to Senate: Reject Health Care Reform Proposal That Fails to Put Patients First

APA is urging the Senate to reject the health care reform proposal unveiled today by Senate Republicans. A vote on this bill is expected to come as early as next week, before lawmakers break for the July 4 recess.

The proposed Senate bill rolls back Medicaid expansion, caps federal funding for the Medicaid program, and removes protections for people with pre-existing health conditions. 

“Eliminating requirements for coverage of key benefits, including mental health and substance use disorders and other patient protections that are part of the Affordable Care Act, will have detrimental impacts for millions,” APA President-Elect Altha Stewart, M.D., said in a press release issued by APA today. “Mental health is critical to overall health and needs to be equally accessible.”

Among other provisions, APA opposes changes to Medicaid that would result in the loss of coverage for many Americans, including the estimated 2.8 million with substance use disorders and 1.3 million with serious mental illness, who gained coverage for the first time under the expansion of Medicaid under the current law. The proposed changes to Medicaid could also mean fewer resources for fighting the nation’s opioid epidemic. 

“The Senate proposal represents a significant move in the wrong direction, resulting in fewer people having access to insurance, fewer patient protections, and less coverage for essential behavioral health care,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in the press release. “We urge the Senate to reject this harmful legislation and start again on a health care bill that puts patients first.”

Before the Senate’s proposal was made public, APA expressed significant reservations about how the bill was being drafted without the input of patient and physician groups. In an all-member email sent Monday night, Levin urged members to act. “Mental health and substance use treatment is a bipartisan issue,” Levin wrote. “Over the years, APA has worked with both sides of the aisle to achieve passage of the Mental Health Parity and Addiction Equity Act in 2008, its expansion to cover mental health and substance use disorders as part of the Affordable Care Act in 2010, and the 21st Century Cures Act in 2016.”

The House version of the bill, according to the Congressional Budget Office (CBO), would leave some 14 million more Americans uninsured next year than under the current law and 23 million more uninsured by 2026. The Senate bill awaits CBO analysis.

Your Voice Counts
APA urges you to contact your senators and speak out against the Senate health care reform bill released today. APA has created a dedicated tool to make it easy for you to voice your opinion via Facebook, Twitter, or phone.

(Image: Mikhail Kolesnikov/Shutterstock)

Clonazepam May Reduce Risk of Relapse in Patients With Panic Disorder

While most patients with panic disorder respond to selective serotonin reuptake inhibitors, benzodiazepines, and/or a combination of the two, the risk of relapse after drug discontinuation is known to be high. A study in the Journal of Clinical Psychopharmacology now suggests that patients who take clonazepam may be at a lower risk of relapse than those treated with paroxetine.

The findings were based on an observational, prospective, six-year follow-up study of patients with panic disorder who participated in an open, randomized trial in which they were assigned to take either clonazepam (0.5 mg/d to 2 mg/d) or paroxetine (10 mg/d to 40 mg/d) for eight weeks. Patients who responded to the assigned monotherapy after eight weeks continued this treatment for 34 months; partial or nonresponders were offered a combined treatment with clonazepam and paroxetine. After 34 months in the long-term study, clonazepam and paroxetine were tapered (four months for clonazepam taper, and six weeks for paroxetine taper).

Of the 95 patients who completed the three-year study, 10 failed to achieve remission. The researchers conducted follow-up assessments with the 85 patients who achieved remission at years 1, 2, 3, 5, and 6 following the discontinuation of clonazepam, paroxetine, or a combination of the two. These assessments evaluated the number of panic attacks the patients experienced per month, Clinical Global Impression-Severity (CGI-S) scores, and the 14-item Hamilton Anxiety Rating Scale (HAM-A) scores. (Patients were considered to have relapsed if they were receiving psychotherapy or medication for panic disorder symptoms, had CGI-S scores greater than 1, or had panic attacks in the month preceding the assessment.)

Over the course of the follow-up period, cumulative relapse rates increased from 50% (n=33) at 1 year to 89.4% (n=76) at 6 years. However, one-year relapse rates were lower in patients previously treated with clonazepam (p=0.001) compared with those treated with paroxetine. Similarly, patients treated with clonazepam showed consistently lower relapse rates at 6 years compared with patients who had not taken clonazepam.

According to lead author Rafael C. Freire, M.D., Ph.D., of the Federal University of Rio de Janeiro and colleagues, the study suggests that despite long-term treatment, patients with panic disorder remain at high risk of recurrence when treatment is discontinued. “Treatment with clonazepam appears to protect these patients against relapse, but further studies are needed to support this affirmation,” the authors concluded.

For related information, see the Psychiatric News article “Benzodiazepines: Experts Urge Balance.”

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APA Members Urged to Voice Opposition to Senate Health Bill Today

APA members are urged to contact their U.S. senators to voice opposition to the health care reform bill now being considered in the Senate. Senators are expected to vote on the bill, which is based on the House-passed American Health Care Act (AHCA), by July 4.

The Senate Republican health care overhaul bill would strip 23 million people of their health insurance coverage and cap the Medicaid program—cutting over $880 billion from the program, which is the largest provider of behavioral health services for psychiatric patients. It would also end the guaranteed inclusion of mental health and substance use disorder treatment services in the list of Essential Health Benefits covered under current law.

Members are encouraged to contact their senators by phone, Twitter, or Facebook. A dedicated page on APA’s website will help members make contact with their Senators through these avenues.

In an all-member email delivered last evening, APA CEO and Medical Director Saul Levin, M.D., M.P.A., urged members to act. “Mental health and substance use treatment is a bipartisan issue,” Levin wrote. “Over the years, APA has worked with both sides of the aisle to achieve passage of the Mental Health Parity and Addiction Equity Act in 2008, its expansion to cover mental health and substance use disorders as part of the Affordable Care Act in 2010, and the 21st Century Cures Act in 2016.”

Senate offices track phone messages and respond to social media. “Your calls and action do count,” Levin said. “We ask that you voice opposition to any bill that would negatively impact patients, and we appreciate your standing with us to do what is right for our patients.”

For more information, see the Psychiatric News article “CBO Says Millions of People Could Lose Coverage Under AHCA.”

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Study of Pregnant Publicly Insured Women Finds Increase in SGA Use

The use of second-generation antipsychotics (SGAs) by pregnant women enrolled in Medicaid rose more than threefold between 2001 and 2010, according to a report in Psychiatric Services in Advance. In contrast, the proportion of women who received first-generation antipsychotics (FGA) remained stable over the 10-year period.

“To help clinicians and patients make informed treatment decisions, there is an urgent need for further studies in this area to examine adverse pregnancy outcomes associated with maternal use of antipsychotics, in monotherapy or polytherapy, as well as studies examining comparative effectiveness of specific antipsychotic agents among pregnant women,” Yoonyoung Park, Sc.D., of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in Boston and colleagues wrote.

Park and colleagues analyzed Medicaid Analytic eXtract (MAX) data (2001–2010) from 1,522,247 pregnancies. MAX contains data on demographic characteristics, hospitalizations, and outpatient visits as well as on medications dispensed by an outpatient pharmacy.

From 2001 to 2010, the number of women who filled at least one prescription for a SGA during pregnancy increased from .4% (n=376) to 1.3% (n=2,044) (p<.001), while the use of FGAs remained stable at about .1%.

The increase in the proportion of women taking SGAs appeared to be driven in part by an increase in quetiapine use, which rose from 0.1% in 2001 to 0.6% in 2010, and aripiprazole, which was introduced in 2002 and was used by 0.4% of women by 2010, the authors noted. 

During the study period, the prevalence of bipolar disorder diagnosis in pregnant women also increased more than threefold (from .7% to 2.5%), while the proportion of pregnant women with bipolar disorder who received antipsychotics increased from 13.6% in 2001 to 23.6% by 2010. The authors noted that the increase in bipolar disorder diagnoses is “consistent with the increase observed for the general population, including children and adolescents.”

Additionally, among the 15,196 women who took antipsychotics at any time during pregnancy, 65.2% also received antidepressants, 24.9% received benzodiazepines, and 22.0% received mood stabilizers; 765 women (5%) received at least one prescription for all four of these drug types at some point during pregnancy.

“Polytherapy with other psychotropic medications, common in this population, deserves more attention with regard to fetal safety,” Park and colleagues wrote. “Because Medicaid pays for close to 50% of all deliveries of babies in the United States, the results reflect the real-world utilization of antipsychotics in a large proportion of pregnant women in the U.S. population.” 

For related information, see the Psychiatric News article “Yes or No: Prescribing Antidepressants to Pregnant Patients,” by Jennifer L. Payne, M.D. 

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New Drug Shows Promising Results in Treatment of Postpartum Depression

In a small sample of women with severe postpartum depression, infusion of the compound brexanolone resulted in rapid, significant reduction in symptoms, according to a study published online this week in The Lancet.

The findings “demonstrate a substantial treatment effect of brexanolone” in a group of patients “for which there are no currently approved pharmacological therapies,” Steven Kanes, M.D., of Sage Therapeutics and colleagues wrote. Sage Therapeutics funded this research, and assisted in the study design, data collection, data analysis, data interpretation and writing of the report.

For the double-blind, randomized, controlled trial, the researchers assigned 21 women with severe postpartum depression (Hamilton Depression Rating Scale [HAM-D] score of at least 26) to a 60-hour, continuous intravenous dose of brexanolone or placebo. To make the sample as representative as possible, the researchers recruited patients from urban, suburban, and rural settings in the United States to receive treatment at four research sites.

By 60 hours, seven (70%) women had achieved remission (HAM-D total score of ≤7) compared to one (9%) in the placebo group. Furthermore, mean HAM-D scores for the women who received brexanolone remained significantly lower for a follow-up period of 30 days compared with the placebo group.

Brexanolone is an allosteric modulator of both synaptic and extra-synaptic GABA-A receptors. The results support the rationale for targeting GABA-A receptors in the development of therapies for the estimated 10% to 20% of birth mothers who suffer from postpartum depression, wrote the researchers.

“Our findings provide the first placebo-controlled clinical support for the role of extrasynaptic GABA-A receptors in the modulation of mood and affective states in any clinical population,” wrote the authors. A treatment with rapid onset of action is considered important in severe postpartum depression because of the adverse impact of the depression on the mother, infant, and family.

Brexanolone, a formulation of the neuroactive steroid allopregnanolone, was found to be generally well tolerated among the study participants. There were no deaths, serious adverse events, or discontinuations. The most commonly reported adverse events in the brexanolone group were dizziness (two brexanolone-treated subjects; three placebo-treated subjects) and somnolence (two brexanolone-treated subjects; no placebo-treated subjects).

The author of an accompanying commentary published in The Lancet commented on the study’s “potentially important implication for our understanding of the pathophysiology of postpartum mood disorders,” but he also raised questions such as “Is this a treatment for postpartum episodes specifically or could it be used generally in depression?”

Brexanolone is currently being evaluated in a phase 3 clinical program under way at various other sites across the country.

For related information, see the Psychiatric News article “Synthetic Oxytocin May Increase Risk of Postpartum Depression, Anxiety” and the Psychiatric Services article “Collaborative Care for Perinatal Depression Among Socioeconomically Disadvantaged Women: Adverse Neonatal Birth Events and Treatment Response.”

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APA Urges Senate to Be Transparent, Inclusive in Crafting ACA Repeal Bill

APA today joined with five other medical associations to raise concerns about how the Senate is developing legislation that would harm patients by repealing and undermining essential health care coverage and patient protections established by the Affordable Care Act (ACA). 

In a letter to Senate Majority Leader Mitch McConnell (R-Ky.) and Senate Minority Leader Charles Schumer (D-N.Y.), the six medical organizations urged the political leaders to “commit to a transparent, deliberate, and accountable process” that allows adequate time for stakeholders to provide input on the impact the proposed legislation would have on patients and their physicians. The letter also calls for public hearings on the proposed bill as well as sufficient time to ensure that the Senate has the Congressional Budget Office (CBO) score on the legislation and other independent analyses available for review well in advance of any vote.

“Proposed legislation revamping our nation’s health care system needs to be worked on in the open, not behind closed doors,” APA President-Elect Altha Stewart, M.D., said in a news release. “We are determined that the voices of patients with mental illness or substance use disorders be heard.”  

The five groups that signed onto the letter with APA were the American Academy of Family Physicians, American College of Physicians, American Osteopathic Association, American Academy of Pediatrics, and the American Congress of Obstetricians and Gynecologists. These groups collectively represent more than 560,000 physicians and medical students. 

APA was part of the same coalition of medical organizations that had expressed strong opposition to the American Health Care Act (AHCA), which the House of Representatives passed on May 4. 

Late last month, the CBO released its score of the AHCA, which it projected would leave some 14 million more Americans uninsured next year than under the current law and 23 million more uninsured by 2026. APA had responded to the news immediately at the time, renewing its call for the Senate to reject the ACA replacement bill in favor of a bipartisan solution. 

This week, APA CEO and Medical Director Saul Levin, M.D., M.P.A., reiterated that message. “We are willing to work with lawmakers on both sides of the aisle in crafting health care legislation that provides adequate coverage to Americans,” he said in a news release. “Allow us to lend our expertise to this important issue. It is crucial that any legislation include mental health and substance use disorder treatment.”

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Lithium Found to Decrease Suicide Risk in Bipolar Patients

Lithium appears to have a protective effect against suicide in patients with bipolar disorder—an effect that was not seen in patients taking valproate, according to a study in AJP in Advance. While previous studies have suggested that lithium treatment reduces risk of suicide, whether the same was true of valproate was less clear.

“Our results, in conjunction with existing literature, indicate that in patients with bipolar disorder and suspected suicidal intentions, lithium should be considered as a suicide preventive strategy, with a balance between efficacy and tolerability,” Jie Song, Ph.D., of the Karolinska Institutet and colleagues wrote.

For the study, the researchers relied on Swedish population-based registers to track outcomes in individuals with bipolar disorder between October 1, 2005, and December 31, 2013. Among the 51,535 patients with bipolar disorder identified, a total of 10,648 suicide-related events occurred in 4,643 individuals (9.0%) during the follow-up period.

When the researchers compared periods when patients were taking either lithium or valproate with periods they were not, they found a 14% reduced rate of suicide-related events for periods when patients were on lithium compared with when they were not (hazard ratio, 0.86); this change was not seen in patients who received valproate treatment (hazard ratio, 1.02). The difference in hazard ratios of suicide-related events between lithium and valproate was statistically significant.

“Since the within-individual analyses drew information exclusively from people who attempted suicide during follow-up, our results demonstrated that the association between lithium and reduced suicide-related events existed even among a high-risk population, which is unlikely to be studied in randomized, controlled trials,” the authors wrote. “Future research on the mechanisms behind the association between lithium and suicidal behavior is warranted and could inform the neurobiology of suicidal behavior.”

For related information, see the Psychiatric News article “Lithium Is Regaining Favor Over Anticonvulsants,” by Jonathan Meyer, M.D., of the University of California, San Diego.

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AMA Calls on Government to Improve Mental Health Care for Children, Families in Detention

The AMA House of Delegates on Monday approved several resolutions aimed at improving the health and mental health care of immigrants and refugees and their families being held in U.S. detention centers. 

At AMA’s annual policymaking meeting in Chicago, delegates approved resolutions that call on the AMA to do the following: 

• Advocate for the health and mental health care of U.S. children in deportation proceedings against their undocumented parents.
• Oppose the expansion of family immigration detention in the United States, oppose the separation of parents from their children who are detained while seeking safe haven, and advocate for access to health care for women and children in immigration detention centers.
• Advocate for protections that prohibit U.S. Immigration and Customs Enforcement (ICE), U.S. Customs and Border Protection, or other law enforcement agencies from using information from medical records to pursue immigration enforcement actions against patients who are undocumented. 
• Issue a public statement urging the ICE Office of Detention Oversight to revise its medical standards governing the conditions of confinement at detention facilities to meet those set by the National Commission on Correctional Healthcare and track complaints related to substandard health care quality.

“The unpredictable stress and isolation associated with detainment have a significant potential to exacerbate and contribute to mental illness,” Laura Halpin, M.D., Ph.D. (pictured above), a first-year psychiatry resident at UCLA and a member of the Resident and Fellow Section, told physicians during a discussion of the issue. “Federal policymakers and responsible agency officials must ensure that detained individuals receive appropriate mental health treatment.”

Delegates will consider further resolutions today supporting international medical graduate (IMG) physicians who may be affected by President Donald Trump’s executive order barring travel from certain countries. A six-member educational panel on the subject of physicians, health care, and immigration policy at the AMA meeting yesterday agreed that the executive order, though held up in courts, may affect whether physicians and researchers from other countries will want to come to the United States.

For related information, see the Psychiatric News article “Executive Orders Usher in Era of Uncertainty for IMGs, Program Directors.”

(Image: Mark Moran)

Adjunctive Liraglutide Found to Reduce Weight Gain, Metabolic Effects From Clozapine, Olanzapine

Patients with schizophrenia who experience weight gain and metabolic disturbances while taking clozapine or olanzapine may benefit from once-daily adjunctive treatment with the anti-diabetic medication liraglutide, reports a study published June 10 in JAMA Psychiatry.

“In overweight or obese patients with schizophrenia spectrum disorders and prediabetes, 16 weeks of liraglutide as an adjunctive treatment to stable treatment with clozapine or olanzapine significantly improved glucose tolerance and glycemic control. At the end of the trial, the placebo-subtracted body weight loss was 5.3 kg,” wrote Anders Fink-Jensen, D.M.Sc., of the University of Copenhagen and colleagues. Liraglutide is a glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes and obesity. 

These findings are encouraging for patients taking these antipsychotics, which are among the most effective for treating schizophrenia but also have the greatest risk of cardiovascular and metabolic side effects, according to the authors.

The study included 103 adults aged 18 to 65 who were diagnosed with a schizophrenia spectrum disorder (schizoaffective disorder excluded) and were receiving stable treatment with clozapine or olanzapine. The participants, who all had prediabetes and a body mass index of 27 or greater, were randomly assigned to 16 weeks of once-daily treatment with subcutaneously injected liraglutide (up to 1.8 mg) or placebo provided in prefilled pen injectors. Every four weeks, participants had blood samples obtained; body weight, waist circumference, and blood pressure measured; and adverse events and alcohol consumption recorded. 

After 16 weeks, patients taking liraglutide had a 23% larger reduction in their two-hour plasma glucose level compared with the placebo group. In the liraglutide group, 30 patients (63.8%) changed status from prediabetes to normal glucose tolerance compared with eight (16.0%) in the placebo group.

Additional benefits observed in the liraglutide group included decreased waist circumference, systolic blood pressure, and low-density lipoprotein cholesterol levels.

Patients in the liraglutide group experienced significantly higher rates of nausea (31 of 50 [62%] vs. 16 of 50 [32%]), but these differences diminished over time, the authors noted.

“Altogether, the liraglutide group experienced significantly fewer serious adverse events, with exacerbation of patients’ psychiatric disease being the most common cause, and no differences in quality of life, daily functioning, or psychiatric disease severity were found,” the authors added.

For related information, see the Psychiatric News article “Aripiprazole May Reduce Some Side Effects of Antipsychotics in Women.” 

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Benzodiazepine Use May Become Long Term When Combined With Antidepressants

The clinician’s decision to start a patient on antidepressants and benzodiazepines at the same time in treating depression should be considered carefully because of potential long-term use and risks associated with benzodiazepines, according to a study published online June 7 by JAMA Psychiatry.

The study found that among adults who started taking an antidepressant simultaneously with benzodiazepine therapy for treatment of depression, 12.3% of new, consistent users (22% of new, sporadic users) became long-term benzodiazepine users, defined as 6 months or longer of continuous use. This outcome was more common among patients with an initial prescription for a longer benzodiazepine days’ supply or long-acting benzodiazepine and recent prescription opioid fills.

Patients with an initial days’ supply of 8 to 15 days, 22 to 35 days, and more than 35 days were more likely to become long-term users than were patients with 1 to 7 days’ supply, the study found. Older adults, patients initiating long-acting benzodiazepines, and patients diagnosed by a psychiatrist compared with a family practitioner also were more likely to become long-time users. The researchers speculated that this type of therapy may be used more with severe depression, but did not measure depression severity in the study.

The researchers used a 2001-2014 claims database of commercially insured adults (aged 18-64 years) with a recent depression diagnosis who began antidepressant therapy and had not used antidepressants or benzodiazepines in the prior year. Of the study’s 765,130 adults (median age, 39 years), 10.6% received the simultaneous antidepressant-benzodiazepine therapy; the proportion of these patients increased from 6.1% in 2001 and peaked at 12.5% in 2012.

An anxiety diagnosis was found to be the strongest determinant of simultaneous use of benzodiazepines with antidepressants—this was true for 24% of new users with a recent unspecified anxiety diagnosis and 39% with a recent panic disorder diagnosis.

“Despite cautions and concerns, benzodiazepines are commonly prescribed during antidepressant treatment … but less is known about the specific practice of simultaneously beginning benzodiazepine therapy with antidepressant therapy,” wrote the authors.

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APA Calls for Senators to Reject Flawed American Health Care Act, Offers Priorities for Moving Forward

APA and the American Psychological Association this week called on the Senate to “avoid major flaws” in the American Health Care Act (AHCA) and craft a bill that would result in more people having coverage for mental health and substance use treatment.

In a letter to Senate Majority Leader Mitch McConnell (R-Ky.) and Senate Minority Leader Charles Schumer (D-N.Y.) dated June 6, the two mental health associations expressed their reservations with the House bill passed May 4.

“We strongly oppose the American Health Care Act, as recently passed by the House. According to the Congressional Budget Office, the AHCA would result in 14 million more people uninsured in 2018 than under current law, and 23 million more people without insurance by 2016,” wrote APA CEO and Medical Director Saul Levin, M.D., M.P.A., and American Psychological Association CEO and Executive Vice President Arthur C. Evans, Ph.D. “Millions more would lose access to treatment, with mental health and substance use services no longer being covered under their benefit package. This is the wrong direction for our country.”

Levin and Evans called on the Senate to retain Medicaid eligibility for Americans below 138 percent of the federal poverty level and to retain the current Medicaid financing structure, without the use of per capita caps or block grants.

“Low-income and uninsured adults have sharply higher rates of serious mental illness as those with insurance and higher incomes,” they wrote. “Medicaid expansion has been particularly helpful in addressing the opioid epidemic, as illustrated by the 700 percent increase in use of substance use treatment services among Kentucky beneficiaries after the state expanded its Medicaid program, and Medicaid’s coverage of 37 percent of spending on buprenorphine in New York.”

The opioid epidemic illustrates the danger of capping federal Medicaid payments, they said. “Private insurance payments for opioid abuse and dependence services increased by 1,375 percent between 2011 and 2015 (from $32 million to $446 million),” they wrote. “Under a system of Medicaid per capita capped payments, tens of thousands of individuals struggling with opioid addiction would have been denied Medicaid coverage and treatment, and thousands more would have died. … States already have significant flexibility in tailoring their Medicaid programs, and can be provided more flexibility without capping federal payments.”

Levin and Evans urged the Senate to also continue to require plans to cover an essential health benefits package that includes mental health and substance use disorder services and behavioral health treatment, and to prohibit insurers from charging higher premiums for people with pre-existing conditions. Further, the pair emphasized the importance of continued investment in research and programs, including retaining the Prevention and Public Health Fund.

“Our nation cannot afford to go back to the days when insurers selectively enrolled individuals to avoid financial responsibility for needed services. Nor can we afford to return to viewing mental health and substance use services as optional,” the leaders wrote. “Rather, we must further reduce the uninsured rate, develop integrated systems of care, and continue to foster an environment in which health plans compete on how efficiently and effectively they can provide services.”

Write Your Senators and Urge Them to Start Over on AHCA

APA members are urged to contact their senators to express opposition to the AHCA and instruct the Senate to set aside the House bill and start over on new legislation that does not put at risk health care for people with mental health/substance use disorders. To make such communication quick and easy, visit the APA Advocacy Center.

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Prohibiting Psychiatric Patients From Owning Guns Misses Mark, Study Suggests

Prohibiting individuals with a history of psychiatric hospitalization from purchasing firearms alone appears unlikely to significantly reduce the number of victims of gun violence, according to a study in Psychiatric Services in Advance.

The multistate study of state prison inmates found that those with a history of psychiatric hospitalization represented a small proportion of violent gun offenders. “Contrary to media portrayals, persons with a history of hospitalization were less likely than those without such a history to target strangers and were no more likely to engage in public shootings or to have multiple victims,” wrote Aaron Kivisto, Ph.D., of the University of Indianapolis.

Kivisto analyzed data from the 2004 Survey of Inmates in State Correctional Facilities, a survey of a nationally representative sample of state prison inmates. Of the 14,499 inmates interviewed at 287 state prisons between October 2003 and May 2004, 6,535 (45%) were incarcerated for violent offenses, and 1,589 (24%) used a firearm in the commission of a crime. A total of 838 gun-violence perpetrators, defined as those incarcerated for a violent offense during which they fired a gun, had data available regarding psychiatric hospitalization prior to incarceration.

Kivisto found that those with a history of psychiatric hospitalization represented just 1 in 8 violent gun offenders and accounted for only 13% of overall gun violence victims. Moreover, 75% of violent gun offenders who did have a history of psychiatric hospitalization obtained firearms from sources not required by federal law to conduct background checks. 

“Central to understanding the potential public health impact of current [gun] policy efforts, such as the NICS [National Instant Criminal Background Check System] Improvement Act aimed at increasing states’ reporting of individuals prohibited from purchasing firearms for mental health reasons, is the recognition that such policies hinge both on the relative contribution of persons with mental illness to the problem of gun violence and on the potential reach of federal regulations to deter at-risk individuals from obtaining firearms,” Kivisto wrote. “The study’s findings suggest that such efforts face challenges on both fronts.” 

Prior hospitalization alone as a variable for predicting violence is far too non-specific, said Jeffrey Swanson, Ph.D., a professor of psychiatry and behavioral sciences at Duke University and expert on gun violence and mental illness, who was not involved with this study. However, he noted that previous studies have shown that there are subgroups within the population of individuals with prior psychiatric hospitalization—especially those who were involuntarily hospitalized and those with a prior history of violence—who may be at higher risk for dangerousness. Swanson emphasized that mental illness is correlated far more highly with suicide by firearms than with violence against others. 

“The real challenge when balancing risks and rights [to gun ownership] is to focus not on mental illness, per se, but on risk factors related to dangerousness to self or others,” Swanson told Psychiatric News. 

For related information, see the Psychiatric News article “Gun Violence Reduction Possible With Combined, Varied Actions.”

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FDA Approves Two-Month Dose of Aristada for Treatment of Schizophrenia

Clinicians will soon be able to offer patients with schizophrenia the option to extend the amount of time between injections of the atypical antipsychotic Aristada (aripiprazole lauroxil). The Food and Drug Administration (FDA) yesterday approved a two-month dose of Aristada for the treatment of schizophrenia.

Aristada, manufactured by Alkermes, was first approved by the FDA in October 2015, with dosages for use every four to six weeks. In August 2016, Alkermes submitted a supplemental New Drug Application (sNDA) to the FDA for a two-month dosing interval of Aristada. The application was based on the results of an open-label trial that compared outcomes in 140 patients with stable schizophrenia who were randomized to receive 441 mg aripiprazole once per month, 882 mg aripiprazole every six weeks, or 1,064 mg aripiprazole every two months.

“Results from the study showed that the 1,064-mg dose of aripiprazole achieved therapeutically relevant plasma concentrations of aripiprazole with a PK [pharmacokinetics] profile that supports dosing once every two months. The most common adverse event for the two-month dosing interval was injection site pain,” the company reported at the time.

“Aristada is now FDA approved in four doses and three dosing-duration options (441 mg, 662 mg, or 882 mg once monthly; 882 mg once every six weeks; and 1,064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and health care providers,” according to a press release issued by Alkermes today.

“The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for two months will be a welcome new treatment option for health care providers, caregivers, and patients,” Joseph McEvoy, M.D., the I. Clark Case Distinguished Chair in Psychotic Disorders at Augusta University and professor emeritus of psychiatry and behavioral health at Duke University Medical Center, said in the Alkermes press release.

According to Alkermes, the two-month dose of the medication is expected to be available in mid-June.

For related news, see the Psychiatric News article “Study Finds Aripiprazole Lauroxil Carries Low Risk of Metabolic Side Effects.”

For related information on long-acting injectables, see the Psychiatric Services article “Hospital Readmission Rates Among Patients With Schizophrenia Treated With Long-Acting Injectables or Oral Antipsychotics.”

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Chronic Pain May Accelerate Memory Decline, Study Reports

Older adults troubled by persistent pain may be at a greater risk of rapid memory decline, according to a study published today in JAMA Internal Medicine.

“Whereas it is known that chronic pain is associated with poorer cognitive performance in cross-sectional studies, this study newly demonstrates accelerated memory decline and increased probability of developing dementia year-on-year at a population level,” wrote Elizabeth Whitlock, M.D., of the University of California, San Francisco, and colleagues. 

Whitlock and colleagues analyzed data collected as part of the Health and Retirement Study (HRS)—a nationally representative cohort of community-dwelling older adults who undergo detailed in-person or telephone interviews every two years. The researchers focused on adults who were 62 years or older in 2000 and answered pain and cognition questions in 1998 and 2000; those reporting being “often troubled by moderate or severe pain” both years were classified as having “persistent pain.” Participants were followed until death, dropout, or evaluation in 2012.

Of the 10,065 adults included in the sample, 1,120 (10.9% of the weighted sample) reported persistent pain at baseline. Participants reporting persistent pain had more depressive symptoms, a greater prevalence of limitations in activities of daily living, and more comorbid medical conditions than those not experiencing pain. 

“Over time, participants with persistent pain experienced a 9.2% more rapid decline in memory score. This translated to a relative 11.8% to 15.9% increased risk of inability to manage medications or finances independently at the end of 10 years, compared with age-adjusted HRS peers,” Whitlock and colleagues wrote. Additionally, “population-level dementia probability increased 7.7% faster in those with persistent pain compared with those without.”

The authors concluded, “For the elderly, maintenance of cognition is crucial for quality of life and functional independence. … Elucidating the nature of the relationship between pain and cognitive decline is the first step toward developing strategies to mitigate it.”

For related information, see the Psychiatric News article “New Dementia Measures Address Disclosure of Diagnosis to Patients.”

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Early Signs of Post-TBI Aggression, Depression May Predict Long-Term Challenges

The presence of aggression and new-onset depression within the first three months of a traumatic brain injury (TBI) may predict how likely it is a person will continue to experience post-TBI aggression over the course of the year, finds a study published this week in the Journal of Neuropsychiatry and Clinical Neurosciences.

“The implication of this is that critical assessment of aggression via evaluation of psychosocial and psychiatric disease burden in the early TBI period can allow for early interventions to potentially prevent progression of aggressive behavior later,” wrote lead author Durga Roy, M.D., of Johns Hopkins University School of Medicine and colleagues. Additionally, the “findings suggest that identification and treatment of depression within the first three months of TBI may reduce the burden of disease that ensues from aggression within the first year postinjury.”

For the study, Roy and colleagues assessed psychiatric symptoms and psychosocial functioning in 103 adults with first-time TBI over 12 months. Overall rates of aggression were 34.3% at three months, 41.1% at six months and 38.0% at 12 months. Verbal aggression was the predominant manifestation, while physical aggression (whether on self, others, or objects) was negligible.

Poor social functioning at three months was also found to be associated with aggression at 12 months. Post-TBI cognitive deficits, substance abuse, and frontal lobe injuries did not show any association with subsequent aggression, however.

“Future studies should focus on effective early screening for new-onset depression after TBI and early psychosocial interventions to improve psychosocial functioning,” the authors concluded.

To read more about this topic, see the Psychiatric News article “Sertraline May Help Prevent Depression Following Traumatic Brain Injury.”

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Recovery-Oriented Cognitive Therapy Benefits Patients With Schizophrenia

Recovery-oriented cognitive therapy (CT-R)—a therapeutic approach that emphasizes a patient’s personal treatment goals—can lead to enduring improvements in low-functioning individuals with schizophrenia, reports a study published today in Psychiatric Services in Advance.

Paul M. Grant, Ph.D., of the University of Pennsylvania and colleagues randomly assigned 60 adults with schizophrenia or schizoaffective disorder to 18 months of CT-R plus standard treatment or standard treatment alone. Standard treatment consisted minimally of antipsychotic medication, but most in this group received some additional services from the local community mental health center. Researchers who were blind to the treatment groups evaluated the study participants at the start of the trial and again 6, 12, 18, and 24 months later.

The researchers found that even though CT-R ended at 18 months, global functioning in the CT-R group remained superior to that in the standard treatment group at 24 months. The CT-R group also showed lower scores for negative symptoms (avolition and apathy) and for positive symptoms compared with participants receiving standard treatment.

“The findings presented here show that these improvements over baseline were maintained across the follow-up period when therapy was withdrawn, supporting the notion that CT-R produces an enduring change in beliefs and skills that enables individuals to continue to maintain gains without their therapist,” Grant and colleagues wrote.

Those with less chronic illness began to show improvement sooner, some as early as six months, with the most prominent benefits evident at the end of active treatment at 18 months. “[T]hose with greater chronicity showed reliable improvements, but they did so later (at 24 months), suggesting that clinicians should not give up on these individuals when it seems that they are not improving as quickly as hoped,” the authors added. “More intensive treatment might quicken their recovery response.”

The CT-R treatment consisted of engaging and establishing a connection with the patient, for example, through music, singing, dancing, or taking a walk, and then working collaboratively with the patient to identify personal, meaningful, and valued goals for the future, such as finding a job, reconnecting with family, developing relationships, and pursuing independent living in the community. Therapists used the cognitive model to help participants overcome obstacles, such as low energy, hallucinations, and disorganization, within a goal-directed framework with personalized treatment targets. Later sessions focused on consolidating gains and preventing relapse.

For related information, see the Psychiatric News article “Psychosocial Treatments Found Effective for Early Psychosis.”

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