CMS Proposes New Rule for Quality Payment Program Under MACRA

The Centers for Medicare and Medicaid Services (CMS) has issued a 962-page proposed rule covering implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The goal, said CMS in a statement, is “a new framework for rewarding health care providers for giving better care, not just more care.”

MACRA replaces the flawed Medicare sustainable growth rate (SGR) formula and modifies and streamlines related quality reporting and electronic health record (EHR) programs. In its place now are two pathways for payment: through the Merit-Based Incentive Payment System (MIPS) or Alternative Payment Models (APMs).

Beginning with reporting in 2017, physicians will receive a composite performance score (CPS) based on how they perform in comparison to an average for other professionals. The CPS will determine maximum payment bonuses and penalties, which will range from 4% in 2019 to 9% starting in 2022. The program measures providers on the basis of quality, resource use, clinical practice improvement, and meaningful use of certified EHR technology (now referred to advancing care information).

Physicians who have sufficient revenue tied to “eligible” APMs can qualify for 5% bonuses and exemption from MIPS reporting requirements. APMs include accountable care organizations, patient-centered medical homes, and bundled payment models.

Aspects of the rule that may be relevant for psychiatry include exemption of “low-volume” providers from MIPS reporting or penalties, the ability of small practices to join together for joint reporting and assessment, flexibility for scoring within MIPS categories, and funding for technical assistance for small practices. There are also advantages for doing MIPS reporting through clinical data registries. APA is now beginning work on the development of a mental health clinical data registry.

“APA supports providing quality care to our patients,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “The APA administration will be analyzing the rule and sharing with our membership how it will affect psychiatric care. We will also provide our members with the tools they will need to meet the new requirements.”

CMS will accept comments on the rule until June 27, and a final rule is expected to be issued by November 1.

For more information, see a brief summary of the rule and a fact sheet with links to additional information.

For more in Psychiatric News about MACRA, see “Value-Based Payment Will Change Practice, Reimbursement.”

Study Shows Importance of Monitoring Mental Health of Cancer Patients

Patients with cancer may be at a heightened risk of some mental disorders immediately before and after being diagnosed with cancer, according to a study appearing today in JAMA Oncology. The findings, according to the study authors, support the need to be attentive to the mental health needs of this patient population starting at the time of cancer diagnostic workup.

Psychiatric comorbidities, such as depression, anxiety, and substance use disorder, are common among patients with cancer. While numerous studies have examined the short- and long-term impact of a cancer diagnosis on mental health, less is known of the mental health impact of diagnostic testing leading to a cancer diagnosis.

To investigate risk changes in several mental health disorders from cancer diagnostic workup to postdiagnosis, Donghao Lu, M.D., of the Karolinska Institutet and colleagues conducted a matched cohort study of people in Sweden from January 2001 through December 2010, totaling 304,118 patients with cancer and more than 3 million cancer-free individuals randomly selected for comparison.

On the basis of  information contained in several Swedish health registers, the authors estimated the time-varying hazard ratios (HRs) of the first clinical diagnosis (made during inpatient or outpatient hospital visit) of depression, anxiety, substance abuse, somatoform/conversion disorder, and stress reaction/adjustment disorder from two years before cancer diagnosis, through the time of diagnosis, and until 10 years after diagnosis. The use of psychiatric medications for patients with cancer was also examined to assess milder mental health conditions and symptoms.

The relative rate for all studied mental disorders started to increase from 10 months before cancer diagnosis (HR=1.1) and peaked during the first week after diagnosis (HR=6.7). Although the rate increase dropped rapidly after this period, the rate remained elevated 10 years later. The rate increase immediately before and after cancer diagnosis was greater among women than men. Among patients with cancer, depression had the highest cumulative incidence during the study, followed by anxiety and stress reaction/adjustment disorder.

Additionally, the authors found that there was increased use of psychiatric medications from one month before cancer diagnosis that peaked about three months after cancer diagnosis and remained elevated two years after diagnosis.

“Although our findings highlight the importance of timely psychological intervention throughout the cancer diagnosis, it remains to be explored whether or not such intervention should be specifically tailored for patients with cancer compared with individuals without such life-threatening conditions,” the authors wrote.

For related information, see the Psychiatric News column "Integrated Psychosocial Care for Cancer Patients” by Jesse Fann, M.D., M.P.H., of the University of Washington.

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Mindfulness-Based Cognitive Therapy May Reduce Relapse in MDD Patients

A meta-analysis published today in JAMA Psychiatry suggests that mindfulness-based cognitive therapy (MBCT) may be just as or more effective in preventing or delaying relapse in patients with recurrent major depressive disorder (MDD) than other types of depression therapies, especially in individuals with pronounced residual symptoms.

MBCT combines the concepts of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness.

“Relapse prevention in recurrent depression is a significant public health problem, and antidepressants are the current first-line treatment approach,” wrote an international team of study authors. “Identifying an equally efficacious nonpharmacological intervention would be an important development.”

For the study, the researchers performed a systematic review of randomized trials published from November 2010 to November 2014. To meet inclusion, studies were required to have compared the effectiveness of MBCT with at least one non-MBCT treatment, such as antidepressant treatment and cognitive psychological education, to prevent symptom relapse in adults with recurrent MDD who were in full or partial remission.

The effectiveness of MBCT treatment was measured by the absence of relapse to depression within 60 weeks of follow-up, measured by the Structured Clinical Diagnostic Interview. The researchers also examined the impact of sociodemographic factors and psychiatric variables on MBCT effectiveness.

Nine trials met inclusion in the meta-analysis, with a total of 1,258 participants. Of the participants who received MBCT, 38 percent had a depressive relapse within the 60-week follow-up, compared with 49 percent among those who did not receive MBCT. Results also showed MBCT to be more effective in people presenting greater depressive symptoms at baseline, compared with those who did not. There was no statistical correlation between MBCT and age, sex, education, or relationship status.

In an accompanying editorial, Richard Davidson, Ph.D., founder of the Center for Healthy Minds at the University of Wisconsin-Madison, wrote that “the opportunity now is to examine in more detail which types of patients benefit most from MBCT, the mechanisms by which MBCT is producing its beneficial change, and how we can better measure the mediators of therapeutic change.”

For related information, read the Psychiatric News article "Mindfulness Program Found to Help Urban Children Cope With Stress."

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Meta-Analysis Suggests Nutraceuticals May Be Effective Adjuncts to Antidepressants

Several commercially sold “nutraceutical” compounds—including S-adenosylmethionine (SAMe), methylfolate, omega-3, and vitamin D—may be effective adjuncts to antidepressants for reducing depressive symptoms, according to a meta-analysis published today in AJP in Advance.

Australian and American investigators searched the literature up to December 2015 for clinical trials that examined any adjunctive nutrient-based intervention for depression and identified 40 studies (31 were randomized, double-blind, and placebo-controlled trials) for analysis. Common trial lengths were 4, 6, and 8 weeks, with a mean sample size of 63 participants and a mean age of 44 years for analysis; a variety of antidepressant pharmacotherapies were used in the studies, which primarily used open inclusion of all SSRIs or commonly specified prescription of fluoxetine, citalopram, or escitalopram.

Statistical analysis revealed a positive effect of the adjunctive intervention in 68% of the clinical trials. The authors reported positive results for replicated studies testing S-adenosylmethionine (SAMe), methylfolate, omega-3 (primarily EPA or ethyl-EPA), and vitamin D, with positive isolated studies for creatine, folinic acid, and an amino acid combination. Mixed results were found for zinc, folic acid, vitamin C, and tryptophan, with nonsignificant results for inositol.

“All of the nutraceuticals reviewed in this article have mechanistic antidepressant activity underpinning their use,” the authors wrote. For instance, omega-3 appears to exert “antidepressant activity potentially through modulation of norepinephrine, dopamine, and serotonin reuptake, degradation, synthesis, and receptor binding; through enhancement of glutathione antioxidant capacity; and through enhancement of cell membrane fluidity.” The anti-inflammatory properties of the compounds examined may also contribute to their antidepressant efficacy, the researchers added.

“Nutraceutical applications in psychiatry are advancing, as reflected in recent international collaborative consensus and position statements discussing the potential of nutraceutical use in psychiatry,” the researchers stated. “[M]uch more work is needed, and while an evolving body of research is strengthening the potential of nutraceuticals (and dietary considerations) as an important element in modern psychiatric practice, we are only beginning to study their potential applications.”

For related information, see the Psychiatric News article “Food May Be a Tool to Consider When Helping Psychiatric Patients.”

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Study Suggests Heavy Cannabis Use Early in Life May Increase Risk of Death

A Swedish study that followed men from the time of military conscription up to age 60 has found that those with a history of heavy cannabis use early in life had a higher risk of death at follow-up than those who never used the drug. The findings were published online Friday in AJP in Advance.

For the longitudinal study, Edison Manrique-Garcia, M.D., Ph.D., of the Karolinska Institutet in Stockholm and colleagues tracked the outcomes of 50,373 men aged 18 to 19, who completed a questionnaire on use of alcohol, tobacco, and other substances at the time of enlisting. Deceased cohort members up to age 60 were identified during the follow-up through the National Cause of Death Register, and overall mortality in the cohort was assessed according to information on the level of cannabis use obtained from the survey at conscription.

A total of 3,918 died during the 42 years of follow-up. Of those who died, 651 (17%) had reported cannabis use at conscription. Subjects with a baseline history of heavy cannabis use had a significantly higher risk of death (hazard ratio=1.4) than those without such a history. The authors found an excess mortality among subjects with psychotic disorders, but the level did not differ between those with a history of cannabis use (ever users: hazard ratio=3.8; heavy users: hazard ratio=3.8) and those without such a history (hazard ratio=3.7). No interaction effect was observed between cannabis use and diagnosis of psychotic disorders with regard to mortality.

“The study is convincing in its finding of increased mortality among those who used cannabis moderately to heavily prior to age 19,” A. Eden Evins, M.D., M.P.H., an associate professor of psychiatry at Harvard Medical School and director of the Massachusetts General Hospital Center for Addiction Medicine, told Psychiatric News. “It will be important now to better understand the causal pathway for the effect of early cannabis use on mortality, particularly whether it is through increased rates of cannabis addiction, which is far more common among those who initiate regular cannabis use in adolescence, other addictions such as alcohol or tobacco, or through other somatic illnesses such as cardiovascular or pulmonary disease,” said Evins, who was not involved in the Swedish study.

For related information, see the Psychiatric News article “Research Identifies Gene Linked to Cannabis-Induced Psychosis.”

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CDC Report on Suicide Underscores Urgent Need to Identify At-Risk Individuals

After a period of rather consistent decline in suicide rates in the United States from 1986 through 1999, a report released today from the CDC’s National Center for Health Statistics shows suicide rates climbed 24% from 1999 through 2014 (from 10.5 to 13.0 per 100,000 people). While the rate increased almost steadily over the period, the average annual percent increase was greater for the second half of this period (2006–2014) than for the first half (1999–2006), with increases in both males and females aged 10 to 74.

Among other statistics, the report revealed the suicide rate for females aged 10 to 14 had the highest percent increase (200%) during the period analyzed, tripling from 0.5 per 100,000 in 1999 to 1.5 in 2014. Women aged 45 to 64—who experienced the highest suicide rates for females in both 1999 (6.0 per 100,000) and 2014 (9.8)—had the second-largest percent increase (63%) since 1999.

While men aged 75 and over had the highest suicide rates overall in 1999 and 2014, the suicide rate for this demographic dropped by 8%, from 42.4 per 100,000 in 1999 to 38.8 in 2014. Men aged 45 to 64 had the second-highest suicide rate for males in 2014 and the largest percent increase (43%) in rates, increasing from 20.8 in 1999 to 29.7 in 2014.

“I believe this report reaffirms that psychiatrists and other providers need to identify individuals at risk for suicide and treat them aggressively,” said APA President-elect Maria Oquendo, M.D. “And while underlying disorders such as depression or substance use need to be addressed, there are also treatment options that specifically target suicidal behavior, such as dialectical therapy and cognitive-behavioral therapy. In addition, safety planning is a simple but valuable intervention to help patients identify triggers for suicidal ideation and have a plan to deal with them.”

Oquendo, a professor of psychiatry and director of residency training at Columbia University Medical Center, also stressed that APA and other parties cannot be complacent about the role of guns in suicide. “This report did show that the percentage of suicides attributable to guns has gone down since 1999, but the raw numbers are still going up,” she said.

For related information, see the president’s column by Renée Binder, M.D., titled “Gun Policy and Suicide Prevention.”

Brief Psychotherapy for Mothers May Benefit Children

Brief psychotherapy sessions offered over the course of a few months may be able to reduce depression in mothers of children with mood and anxiety disorders and lead to improvements in the children as well, according to a study published in the Journal of the American Academy of Child and Adolescent Psychiatry. The findings underscore the benefits of psychotherapy for families in which both mothers and children have psychiatric illnesses.

Holly Swartz, M.D., a professor of psychiatry at the University of Pittsburgh, and colleagues randomly assigned mothers of children aged 7 to 18 with at least one mood or anxiety disorder to receive interpersonal psychotherapy (IPT-MOMS; n=85)—a brief version of interpersonal psychotherapy specifically addressing mother-child relationship problems—or brief supportive psychotherapy (BSP; n=83)—an active control in which the patient determines the treatment agenda. Mothers were offered nine weekly 45-minute psychotherapy sessions over a three-month period. Mother and child participants were evaluated at the start of the trial and again every three months over one year.

Mothers attended an average of 7.5 psychotherapy sessions over three months. The researchers found that IPT-MOMS and BSP yielded comparable maternal response rates (defined as greater or equal to 50% reduction in the 25-item Hamilton Rating Scale for Depression), and these improvements were maintained throughout the year. Despite the similar outcomes of both treatment groups, mothers reported greater satisfaction with IPT-MOMS than BSP.

Children of mothers with depression also improved, but these improvements lagged three to six months behind maternal improvement. The study also revealed that children of mothers in the IPT-MOMS group had significantly fewer outpatient visits, and their antidepressant use from baseline to follow-up fell compared with the children of mothers in the BSP group. 

“This suggests that compared to BSP, the interpersonally focused IPT-MOMS may enable mothers to help their children achieve similar improvements in mood and functioning with fewer psychiatric services and less medication exposure,” the authors wrote. 

“Brief psychotherapy poses no teratogenic risk to mothers of child-bearing potential, requires limited therapist time, and imposes only limited additional burden on mothers juggling their children’s mental health needs with their own. … Having evidence of efficacy and low burden, these therapies should be offered to vulnerable families. When mothers are treated, one can anticipate a three- to six-month delay in improved child functioning, information that can help providers and families plan interim family support,” they concluded.

For related information, see the Psychiatric News article “Family-Based Intervention May Help Prevent Anxiety Disorders in Children" and the Psychiatric Services study "PRogram In Support of Moms (PRISM): Development and Beta Testing."

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Study Highlights How Correlates of Mental Health Service Use Differ Between Younger, Older Adults

Unlike older adults, full-time employment and living with a significant other do not appear to increase the likelihood that young adults will use mental health services, according to a study published in Psychiatric Services in Advance.

“These results highlight how correlates of mental health service use ... differ among young adults compared with results from the adult literature,” the study authors wrote. “[The] findings reinforce the need to examine correlates that may be unique to young adults… and the need to tailor mental health services to close service use gaps during this period.”

To examine rates of mental health service use among young adults with mental illness and correlates of use of mental health services, researchers from RTI International, the Substance Abuse and Mental Health Services Administration, and the National Institute of Mental Health analyzed data collected on young adults aged 18 to 26 who participated in the 2008-2012 National Survey on Drug Use and Health (NSDUH).

Within the full NSDUH sample of young adults, 18.8% (n=22,600) were estimated to have a mental illness. Among these individuals, 20.4% used outpatient services, 3.6% used inpatient services, and 25.4% used psychotropic medication.

Similar to that reported in the literature on adult mental health service use, young adult females made greater use of outpatient and medication services compared with males, residents of metropolitan counties were more likely to use outpatient services compared with residents of nonmetropolitan counties, and African Americans and Latinos were less likely to use outpatient and medication services compared with non-Hispanic whites. Unlike older adults, young adults employed full time were less likely than those who were unemployed to receive services, and living with a partner (versus living alone) was not associated with a likelihood of using outpatient services—as has been reported in older groups.

“[These] results support the unique nature of young adulthood and the need to tailor mental health services to close gaps in service use during this developmental period,” the authors concluded.

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Lisa Dixon, M.D., M.P.H., a professor of psychiatry at Columbia University Medical Center and the director of the Division of Behavioral Health Services and Policy Research in the Department of Psychiatry, was recently appointed by APA’s Board of Trustees to be the new editor of Psychiatric Services effective January 1, 2017. In her new role, Dixon will oversee and ensure the quality of research submitted and published by Psychiatric Services through strategic outreach to top researchers.

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Sen. Franken Among Those Honored for Efforts to Reduce Incarceration of Mentally Ill People

The Stepping Up Summit, which concluded today in Washington, D.C., brought together teams from 50 U.S. counties to advance the national movement to reduce the number of people with mental illness in America’s jails.

The teams included mental health professionals, police and sheriff’s department personnel, and local elected officials. They hashed over ways to use data and break down organizational barriers to divert people with mental illnesses from the criminal justice system in the first place, treat those who must remain in custody, and find ways to connect them with mental health and other services in their communities after release from jail.

Working across disciplines was a key to the success of the Stepping Up Initiative, said APA President Renée Binder, M.D., a professor of psychiatry at the University of California San Francisco.

“Everyone partnering together can make a difference,” said Binder, who called on the attendees to work not only on jail diversion in their own localities but to inform the public and lobby Congress to pass the Comprehensive Justice and Mental Health Act of 2015.

Last evening, APA and the APA Foundation presented the first-ever American Psychiatric Excellence (APEX) Awards to seven people in recognition of their advocacy to reduce the number of Americans with mental illness in prisons and jails.

They included Sen. Al Franken (D-Minn.; photographed above with Binder and APA CEO and Medical Director Saul Levin, M.D., M.P.A.); House Minority Leader Nancy Pelosi (D-Calif.); Florida State Sen. Miguel Díaz de la Portilla (R-Miami-Dade); ABC and NPR news commentator Cokie Roberts; and three actors from the hit Netflix series “Orange Is the New Black”: Natasha Lyonne, Dascha Polanco, and Matt McGorry.

Full coverage of the Stepping Up Summit and APEX Awards event will appear in a future issue of Psychiatric News. For more in Psychiatric News on the campaign to end the overrepresentation of people with mental illness in America’s jails, see “Senators Urged to Break Cycle of Jailing People With Mental Illness.”

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Prolonged Exposure, CBT May Accelerate PTSD Recovery, But Not Change Long-Term Prevalence

Treating patients with posttraumatic stress disorder (PTSD) with exposure therapy or cognitive-behavioral therapy (CBT) appears to hasten recovery compared with antidepressant therapy, but the early interventions do not reduce the prevalence of the disorder three years later. The findings, published in the Journal of Clinical Psychiatry, emphasize the occurrence of persistent, treatment-refractory PTSD in a subset of survivors, according to the study authors.

For the study, the researchers randomly assigned adults with PTSD to receive exposure therapy (n=63), CBT (n=40), escitalopram (n=23), or placebo (n=23) for 12 weeks; an additional 82 patients declined treatment but were followed as well. The researchers evaluated PTSD in the participants (using the Clinician-Administered PTSD Scale, or CAPS) at five months and again three years later.

At the five-month assessment, the prolonged exposure and cognitive therapy groups showed lower levels of PTSD symptoms and prevalence of PTSD (21.4% and 18.2%, respectively) than the SSRI, placebo, and no-intervention groups (61.9%, 55.6%, and 43.8%, respectively). At the three-year assessment, however, the prevalence rates were closer together (between 28% and 46% among all groups); in addition, all the groups had similar CAPS scores (exposure therapy=31.51; cognitive therapy=32.08; escitalopram=34.31; placebo=32.13; and no intervention=30.59) and similar rates of secondary outcomes including depression status, employment status, and global functioning.

“What this study tells us at its core is that there is a significant public health challenge ahead. Individuals [who are] continually expressing initial PTSD symptoms and who are resistant to early treatment should be the focus of future research," said lead study author Arieh Shalev, M.D., the Barbara Wilson Professor of Psychiatry at NYU Langone Medical Center, in a press release.

To read about other therapies for patients with PTSD symptoms, see the Psychiatric News article “Attention-Control Training Reduces PTSD Symptoms.”

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Mixed Depression May Be More Common Than Previously Thought

A study published today in AJP in Advance suggests the presence of “mixed features” (concurrent manic and depressive symptoms) is more common in patients with bipolar disorder—particularly in women—than may be diagnosed using the criteria in DSM-5.

“Our results raise the possibility that relaxing the diagnostic criteria for the mixed features specifier ... may yield greater sensitivity for identifying patients with mixed depression,” Shefali Miller, M.D., a clinical assistant professor of psychiatry and behavioral sciences at Stanford University, and colleagues wrote.

The researchers analyzed the outcomes of 907 adult outpatients with bipolar disorder across 14,310 visits between 1995 and 2002. At each visit, mania and depression symptoms were assessed using the Inventory of Depressive Symptomatology–Clinician-Rated Version (IDS-C) and the Young Mania Rating Scale (YMRS). Patients with an IDS-C score of greater or equal to 15 and a YMRS score between 2 and 12 at the same visit were classified as having mixed depression.

The presence of mixed depression was observed in 2,139 visits (14.9% of total) and among 584 patients (64.4% of total). Those classified as having one or more mixed depression visits also had more symptomatic visits and fewer non-depressed visits compared with those with no mixed depression visits. DSM-5-based definitions of mixed depression (ranging from narrower definitions requiring three or more nonoverlapping YMRS items concurrent with an IDS-C score of greater or equal to 15, to broader definitions requiring two or more nonoverlapping YMRS items) yielded lower mixed depression prevalence rates (6.3% and 10.8% of visits, respectively).

The authors also found that women were significantly more likely than men to experience subthreshold hypomania during visits with depression (40.7% compared with 34.4%). In both groups, however, visits with mixed depression were associated with higher scores on all individual YMRS items, notably language-thought disorder, speech, and increased motor activity—three YMRS items that a previous study suggested were predictive of antidepressant treatment–emergent mania.

“The present findings suggest that the presence of mixed symptoms during depression visits may signal heightened risk for antidepressant-induced mania, warranting particular caution in clinical decision making,” the authors wrote.

For more on the study and the significance of the findings, see a related video by American Journal of Psychiatry Deputy Editor A. John Rush, M.D.

For other related information, see the Psychiatric News article “Lurasidone Effective in Treating Depression With Mixed Features.”

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Targeted Deep Brain Stimulation May Reduce Symptoms of Treatment-Resistant Depression

Deep brain stimulation (DBS) of the ventral anterior limb of the internal capsule (vALIC) may reduce depressive symptoms in patients with treatment-resistant depression, according to a report online in JAMA Psychiatry.

“To our knowledge, this is the first study showing the efficacy of deep brain stimulation of the ventral anterior limb of the internal capsule that cannot be attributed to placebo effects,” the researchers wrote.

The study used a novel trial design to evaluate targeted stimulation of the vALIC: 25 patients with treatment-resistant depression first received an open-label treatment with DBS in an “optimization” phase until stable response was achieved; 16 patients were then randomized to receive active treatment for six weeks followed by a sham for six weeks, or a sham treatment for six weeks followed by active treatment for six weeks.

In the optimization phase, which lasted about 52 weeks, the main outcome measured was the change in the investigator-rated score of the 17-item Hamilton Depression Rating Scale (HAM-D-17). Patients were classified as responders to treatment if they had a 50 percent or greater decrease on the HAM-D-17 score after treatment compared with baseline. In the crossover phase, the primary outcome was the difference in the HAM-D-17 scores between active and sham DBS.

Ten of the 25 patients (40%) were classified as responders in the open-label optimization phase and six (24%) were classified as partial responders. The average HAM-D-17 scores decreased from 22.2 at baseline to 15.9, and the mean time to first response in responders was 53.6 days after the start of the factor optimization. In the crossover phase, patients (including both responders and non-responders in the optimization phase) scored significantly lower on the HAM-D-17 scale during active treatment than during sham DBS. Regardless of responder status, the authors reported that patients tolerated vALIC DBS well.

In an editorial accompanying the study, Helen Mayberg, M.D., a pioneer in deep brain stimulation, and colleagues noted the unique study design: “The 40 percent open-label response rate demonstrated [in the study] is similar to that reported in the first open-label study of vALIC DBS for TRD. However, it is the second phase of this study—discriminating effects of active versus sham stimulation—that is most compelling. …. With increasing interest in targeted circuit modulation for depression and other psychiatric disorders, the … study further highlights the need to seriously consider customized trial designs in planning any invasive device trials, be it DBS, vagus nerve stimulation, or a future novel technology.”

Mayberg and colleagues concluded, “A cynical reading of the study ... might lead to the conclusion that the labor-intensive and expert-driven tuning of the DBS device required for treatment response makes this a nonviable clinical intervention for TRD. On the contrary, we see a tremendous opportunity to retrospectively characterize the various features that best define patients who responded well to this treatment.”

For related information, see the American Journal of Psychiatry article “Deep Brain Stimulation for Treatment-Resistant Depression: Follow-Up After 3 to 6 Years” and the Psychiatric News article “Three Leaders Discuss Science, Advocacy, and Language of Mental Health.”

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Investing in Global Mental Health Could Save Billions, Report Suggests

Scaling up treatment for people living with depression and anxiety disorders around the world can lead to billions of dollars in savings, according to a study published yesterday by the World Health Organization (WHO).

Depression and anxiety not only contribute to lost health, but lost economic output. In 2010, an estimated $2.5 to $8.5 trillion in lost output was attributed to mental, neurological, and substance use disorders worldwide. While previous international economic studies of mental health have examined the economic effect of these disorders, the cost-effectiveness of different intervention strategies, and the cost of scaling up care, these studies had not evaluated the value of both economic and health benefits of intervention scale up.

To estimate the global return on an investment in a scaled-up response to depression and anxiety disorders worldwide, Dan Chisholm, Ph.D., and colleagues calculated treatment costs and health outcomes in 36 countries between 2016 and 2030, assuming a linear increase in depression and anxiety treatment coverage. The analysis showed that the estimated cost for a modest increase in mental health care for depression and anxiety would amount to $147 billion ($91 billion for depression and $56 billion for anxiety disorders), a value of $399 billion in economic benefits and health returns.

“Notwithstanding the general limitations of any projection modelling study, the analysis suggests that the investment needed to substantially scale up effective treatment coverage for depression and anxiety disorders in the 36 countries included in this analysis is substantial… Extending the scope to the 20% of the world’s population not living in the 36 countries represented in the study would increase the cost by about 25% to $184 billion,” the authors wrote. “However, the returns to this investment are also substantial, with benefit to cost ratios of 2.3 to 3.0 when economic benefits only are considered, and 3.3 to 5.7 when the value of health returns is also included.”

“The Chisholm study brings rigor to the economic case, but there are many other important reasons to consider enhanced investment in global mental health, not least of which are justice, equity, human rights, and the reduction of suffering,” past APA President Paul Summergrad, M.D., chair of the Department of Psychiatry at Tufts University School of Medicine, wrote in a related commentary.

Summergrad outlined several actions to help advance the global mental health infrastructure before concluding, “…to achieve a sustained effect on global mental health, major international organizations, governments, and foundations will need to be engaged. The publication of this report is therefore timely, coinciding with the first-ever joint meeting of the World Bank and WHO on the global economic effect of depression and anxiety on April 13 to 14, 2016. This is a very important initial step, but only a predicate to overdue and much needed bold action.”

Image courtesy of World Health Organization

Experts Caution More Research Is Needed to Understand Link Between Maternal SSRI Use, Depression in Offspring

Prenatal exposure to selective serotonin reuptake inhibitors (SSRIs) was associated with increased rates of depression diagnoses in early adolescence, according to a report online in the Journal of the American Academy of Child and Adolescent Psychiatry. The study is the first to investigate the incidence of psychiatric diagnoses in offspring prenatally exposed to SSRIs as far out as adolescence.

Finnish and American researchers used Finnish national birth registry data to determine the cumulative incidence of depression and other mental illnesses in the offspring of four groups of mother-offspring dyads: those exposed to SSRIs during pregnancy (n=15,729); those exposed to psychiatric disorder but not to antidepressants (n=9,651); mothers who used SSRIs only before pregnancy (n=7,980); and those unexposed to either antidepressants or psychiatric disorders (n=31,394).

They found the cumulative incidence of depression among offspring exposed prenatally to SSRIs was 8.2% by age 14.9 years, compared with 1.9% in the psychiatric disorder/no medication group and to 2.8% in the SSRI-discontinued group.

Authors and reviewers of the study emphasized in interviews with Psychiatric News the importance of treating maternal depression. “…Until either confirmed or refuted, these findings must be balanced against the substantial adverse consequences of untreated maternal depression,” the authors wrote.

The study was based on previous animal studies by Jay Gingrich, M.D., Ph.D., of Columbia, that suggested that SSRIs have an adverse effect on the developing fetal brain. He told Psychiatric News that further research will try to pinpoint antidepressant medications, dosages, titration schedules, and periods during pregnancy when treatment might be more or less safe.

“Ideally, what we will try to do in the next three years is gain enough new information so we can really help clinicians and their patients have some concrete data,” he said. “We know dose and mechanism of action matter, and timing [during pregnancy] matters a lot.”

Past APA President Nada Stotland, M.D. (pictured above), emphasized the stigma surrounding depression, especially for expectant mothers who are concerned about the welfare of their offspring. “Despite repeated attempts to formulate an algorithm, there is no way to get beyond the need to make treatment decisions on a case-by-case basis, taking into account past history of depression and response to treatment, current severity of depression, access to quality psychotherapy, and the patient’s concerns and preferences,” she said. “Somehow we hear far less, if anything, about medications needed during pregnancy to treat non-psychiatric medical conditions. Women depressed during pregnancy are already anxious about causing harm to their babies.”

Lead authors were Heli Malm, M.D., Ph.D., of Helsinki University, and Andre Sourander, M.D., Ph.D., Alan S. Brown, M.D., and Myrna Weissman, Ph.D., of Columbia University and the New York State Psychiatric Institute.

For related information, see the Psychiatric News article “Study Reports Risks, Benefits of SSRIs Taken During Pregnancy.”

Escitalopram May Reduce Risk of Relapse in People With Body Dysmorphic Disorder

A study published last Friday in AJP in Advance suggests that maintenance use of escitalopram can reduce the risk of relapse in patients with body dysmorphic disorder (BDD) while also continuing to improve symptoms of this common yet understudied disorder.

BDD is often a severe disorder, characterized by distressing or impairing preoccupations with nonexistent or slight defects in appearance and repetitive behaviors performed in response to appearance concerns. Previous research has suggested acute treatment with selective serotonin reuptake inhibitors such as escitalopram can reduce symptoms of BDD, but little is known of the long-term effectiveness of the medications or the risk of relapse when the medications are discontinued.

For the study, 100 adults with BDD received open-label escitalopram for 14 weeks. Patients who responded to escitalopram (defined as greater or equal to 30% reduction in the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder [BDD-YBOCS] score from baseline) were then randomly assigned to six additional months of treatment with continuation monotherapy with escitalopram or discontinuation of escitalopram and substitution with placebo. Relapse of BDD was defined as a 50% or greater loss of BDD-YBOCS improvement that had occurred during the first phase of the study, plus a BDD-YBOCS score of greater than 20 and a rating of “much worse” or “very much worse” on the Clinical Global Impressions Scale for body dysmorphic disorder symptoms.

A total of 81% of the patients who completed the open-label phase of the study achieved BDD symptom response. At the conclusion of the second phase, the time to relapse was significantly longer among patients taking escitalopram than those taking placebo (hazard ratio=2.72); the overall prevalence of relapse was also reduced (18% for escitalopram versus 40% for placebo). Additionally, 35.7% of the escitalopram-treated patients continued to show further improvement in the severity of their BDD symptoms.

“These findings are particularly relevant because body dysmorphic disorder is often chronic,” Katharine Phillips, M.D., the director of the Body Dysmorphic Disorder Program at Rhode Island Hospital, and colleagues wrote. The researchers noted that additional studies are needed to evaluate the effectiveness of escitalopram over longer periods of time as well as “whether treatment with CBT for body dysmorphic disorder will decrease the risk of relapse when an effective medication is discontinued.”

To learn more about BDD, see the Psychiatric News column “How to Recognize, Treat Body Dysmorphic Disorder.”

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Study Identifies Ketamine Dosing Frequencies for Maintaining Efficacy Over 15 Days

Single infusions of ketamine have been shown to produce a rapid antidepressant effect, but past studies show the average duration of response is less than one week. A study published today in AJP in Advance suggests that administering ketamine intravenously two or three times weekly could help to sustain the antidepressant effects of ketamine in patients with treatment-resistant depression over 15 days.

For the multicenter, double-blind trial, Jaskaran Singh, M.D., of Janssen Research and Development, and colleagues randomly assigned 68 patients with treatment-resistant depression to one of the four treatment groups: intravenous ketamine (0.5 mg/kg) two or three times weekly or intravenous placebo two or three times weekly, for up to four weeks.

The mean change in Montgomery-Åsberg Depression Rating Scale score from baseline to day 15 was significantly improved in both ketamine groups (−18.4 and −17.7 in twice-weekly and thrice-weekly groups, respectively) compared with the respective placebo groups (−5.7 and −3.1 in twice-weekly and thrice-weekly groups, respectively). There was no significant difference in MADRS scores between the two dosing regimens evaluated.

Adverse events included dissociative symptoms for up to three hours postinfusion, and treatment-related discontinuation (for nausea or irritability) occurred with only two patients.

“Treatment-resistant depression is a chronic condition, and studies with a longer duration are warranted to fully characterize whether the clinical benefits of ketamine can be maintained, and if so, whether they can be sustained despite reductions in the dosing frequency during chronic treatment,” the authors wrote.

Janssen Research and Development funded this study.

For related information, see the Psychiatric News article “APA Task Force to Address ‘What’s Next?’ for Ketamine.”

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Researchers Estimate 1 in 13 People Worldwide Will Have Psychotic Experience Over Lifetime

According to a study in Schizophrenia Bulletin, approximately 1 in 13 people worldwide will have at least one psychotic experience by the time he or she reaches the age of 75. For most, the first experience will occur in adolescence or young adulthood, but the report suggests that nearly a quarter will have their first experience after they reach 40. The findings may help to advance the understanding of how psychotic experiences unfold across the lifespan and interact with mental disorders.

To determine the age of onset of psychotic experiences and the projected lifetime risk of such experiences, an international team of researchers led by John McGrath, M.D., Ph.D., of the University of Queensland in Brisbane, Australia, analyzed data collected as part of the World Health Organization World Mental Health surveys. A total of 31,261 adult respondents across 18 countries were asked questions about whether they had ever experienced hallucinations or delusions, the frequency of the psychotic experiences, and their age at the time the first experience took place.

Based on the responses to the survey, the researchers projected the lifetime risk for psychotic experiences to be 7.8% (indicating that approximately 1 in 13 people is expected to have one psychotic experience by the age of 75). The median age of onset for psychotic experiences based on projected lifetime estimates was 26 years, but the range of age of onset was wide (17 to 41 years). The researchers also found that those with more types of psychotic experiences had an earlier age of onset.

“Describing the AOO [age of onset] of PEs [psychotic experiences] alongside type and frequency metrics allows us to build a more nuanced understanding of how PEs relate to mental disorders across the lifespan. In particular, these metrics may provide an empirical framework to better understand shared and discrete features of PEs and clinical psychotic disorders,” the authors wrote.

The researchers added that age-related cognitive decline and/or aging-related sensory impairments may drive the emergence of psychotic experiences later in life, but noted that additional studies are needed to explore this relationship.

For related information, see the American Journal of Psychiatry author spotlight video in which McGrath describes his recent AJP study examining the bidirectional associations between psychotic experiences and mental disorders.

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People With Restless Leg Syndrome May Be at Increased Risk of Psychiatric Comorbidities

A study published in the Journal of Neuropsychiatry and Clinical Neurosciences shows that people with restless leg syndrome (RLS)—a neurological disorder characterized by an uncomfortable sensation in the legs, which worsens or appears in the evening or night during rest and improves or disappears with movement—may be at increased risk for psychiatric comorbidities. The findings suggest that clinicians should regularly perform psychiatric assessments of patients with RLS, as this may inform treatment options.

“Psychiatric comorbidities in RLS present two challenging issues in clinical practice: first, a psychiatric comorbidity may complicate the diagnosis of RLS, which is based on subjective reports and requires careful recognition of the so-called ‘RLS mimics’ conditions; and secondly, most antidepressant and neuroleptic drugs worsen RLS symptoms, which may pose a challenge for treatment,” wrote the team of neurologists and psychiatrists from Bern University Hospital and the University of Zurich.

To determine the type and frequency of psychiatric comorbidities in patients with RLS and characterize patients with RLS with and without psychiatric disorders, the researchers performed neurological exams and psychiatric assessments (based on based on the Composite International Interview for DSM-IV) of 49 drug-naïve patients aged 18 to 65 who were diagnosed with RLS. The participants were also asked questions about the severity of RLS, quality of life, and daytime sleepiness, and data on periodic limb movements (PLMs) was collected over the course of several nights. (PLMs during wakefulness or sleep occur in more than 80% of patients with RLS.)

A psychiatric diagnosis was identified in 39% of study participants, with such comorbidities being associated with higher symptom severity for RLS. Among those patients who met criteria for a psychiatric condition, 18.3% had a somatoform disorder, 16.3% had a depressive disorder, and 12.2% had an anxiety disorder. The researchers found that RLS preceded depressive symptoms in 75% of patients with the mood disorder, whereas anxiety and/or panic disturbances were observed prior to RLS symptoms in 83% of patients. Patients with a psychiatric comorbidity also had significantly fewer PLMs than those without a psychiatric comorbidity—a factor the authors suggested may be due to differences in the sleep patterns of patients with psychiatric comorbidity.

“A detailed psychiatric examination and identification of psychiatric comorbidity is essentially needed to better differentiate and treat patients with RLS. The PLM index seems to be useful to differentiate RLS from RLS with psychiatric comorbidity,” the authors concluded.

For more information, see the Psychiatric News article “New DSM Guide Describes Changes to Eating, Elimination, Sleep Disorders Criteria.”

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Race, Medical Comorbidity May Predict Antidepressant Nonadherence Among Veterans

Race and general medical comorbidity appear to be the main predictors of nonadherence to antidepressant medication among veterans treated for depression, according to a study appearing in Psychiatric Services in Advance. The findings suggest ways that integrated care models, such as the VA’s Primary Care Mental Health Integration (PC-MHI) initiative, may be able to address nonadherence among veterans.

Researchers at the University of Michigan and the Veterans Administration, Ann Arbor, evaluated correlates of antidepressant nonadherence among 311 older veterans aged 60 and older with depression whose physicians had recommended antidepressant treatment. Study participants were recruited from three VA medical centers in Michigan (Ann Arbor, Detroit, and Battle Creek) from 2008 to 2011.

Participants were interviewed shortly after receiving the recommendation for antidepressant treatment and again four months later. During the initial interview, researchers collected patient demographic data, including age, gender, race, education level, and marital status, and assessed medical illness burden and cognitive function of the participants. During the follow-up interview, the researchers asked participants how consistently they took their medication in the week prior to the interview. Patients who never initiated the antidepressant medication or who missed two or more daily doses in a given week were rated nonadherent.

At the four-month follow-up, overall self-reported nonadherence to antidepressant treatment was 29%. Nonadherent individuals were significantly more likely than adherent participants to be African American, have no spouse or significant other, and have greater general medical comorbidity. Nonadherent participants were also significantly more likely than adherent participants to have been prescribed the antidepressant in a primary care setting rather than a mental health setting.

“Such patients may require interventions more tailored to their specific needs and barriers. ... the beliefs associated with nonadherence are amenable to intervention strategies, such as the Treatment Initiation Program, which blend elements of psychoeducation, motivational interviewing, and problem solving and have been successfully used with older adults,” the authors wrote. “Similarly, PC-MHI providers could assist individuals with high levels of medical comorbidity linked to polypharmacy with strategies to enhance adherence, such as using pillboxes or electronic medication dispensers. Patients may also need encouragement to discuss concerns about side effects with their providers.”

For related information, see the Psychiatric News article “How a VA Facility Integrates Primary and Mental Health Care.”

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Citalopram May Improve Several Neuropsychiatric Symptoms in Alzheimer's

The benefits of treating patients with Alzheimer’s disease (AD) with citalopram may extend beyond the medication’s ability to reduce agitation, according to a study published Friday in AJP in Advance. The study found patients with AD who took the medication were also less likely to be reported as showing delusions, anxiety, or irritability compared with those in the placebo group.

The findings, which are based on a secondary analysis of the Citalopram for Agitation in Alzheimer’s Disease (CitAD) study, suggest citalopram may offer a therapeutic alternative to antipsychotics, which are commonly prescribed to treat agitation and irritability in Alzheimer’s patients. However, the authors cautioned that dosage constraints must be considered because of citalopram’s adverse-effect profile in this population.

For the CitAD study, 186 individuals who were diagnosed with probable Alzheimer’s disease and “clinically significant agitation” were randomly assigned to receive citalopram (30 mg/day) or placebo daily for nine weeks. Participants in the citalopram group showed a significant reduction in agitation compared with those in the placebo group, according to the Neurobehavioral Rating Scale agitation subscale and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change.

In the current analysis, the authors examined the effects of citalopram treatment on neuropsychiatric symptoms in addition to agitation, as rated on the Neuropsychiatric Inventory (NPI). (In the primary analysis of CitAD, the researchers saw that citalopram reduced overall NPI scores, but not the agitation subdomain, suggesting improvements in other symptoms might be driving patient improvement.)

After nine weeks, participants in the citalopram group were significantly less likely to have reports of delusions (odds ratio=0.40), anxiety (odds ratio=0.43), and irritability (odds ratio=0.38) compared with the placebo group. Median domain scores among the patients with reports of a symptom at week 9 were lower in the citalopram group compared with the placebo group for hallucinations, but higher for sleep/nighttime behavior disorders.

“Citalopram at a dosage of 30 mg/day shows efficacy for the treatment of agitation and appears to be similarly effective for a broad range of concomitant neuropsychiatric symptoms, particularly delusions, anxiety, and irritability/lability,” the authors wrote. “While citalopram is a therapeutic option for the treatment of agitation in Alzheimer’s disease even when psychotic symptoms are present, the concerning side effects of cognitive worsening and delayed cardiac repolarization seen in this study as well as safety concerns with depressed elderly patients urge dosage constraints and caution.”

To read about more findings arising from the CitAD study, see the American Journal of Psychiatry article “Heterogeneity of Treatment Response to Citalopram for Patients With Alzheimer’s Disease With Aggression or Agitation: The CitAD Randomized Clinical Trial.”

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Blood Test May Predict Patients With Concussions Days Later

A blood test may be able to detect evidence of a concussion up to a week after the injury occurred, reports a study published in JAMA Neurology. If validated, this simple test could greatly expand the window for diagnosing concussions, especially in patients with mild or moderate traumatic brain injury (TBI).

In recent years, the proteins glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) have emerged as promising biomarkers for mild TBI. Both proteins are known to become elevated after a head injury and are able to pass the blood-brain barrier.

To understand the behavior of these proteins over days after injury, a team of researchers took repeated blood samples from 584 patients who had been admitted to a trauma center (325 were diagnosed with a mild to moderate traumatic brain injury [MMTBI]; 259 had trauma without MMTBI) over one week. Computed tomography scans of the head were performed in 96.9% patients with MMTBI and in 37.5% trauma patients without MMTBI.

The researchers found that both GFAP and UCH-L1 were detectible within 1 hour of injury. GFAP reached a peak at 20 hours after injury and steadily decreased over 72 hours but was still detectable at 7 days. In contrast, UCH-L1 rose more rapidly after injury than GFAP, reached a peak at 8 hours, and decreased steadily over 48 hours.

When assessing if protein levels could distinguish trauma patients with and without MMTBI, GFAP proved quite predictive, ranging from 80-97% over the various time points (peaking at 97% between the 36-60 hour mark); UCH-L1 was not as accurate, peaking at 77%. GFAP also proved extremely accurate in predicting the patients with MMTBI who required a neurosurgical intervention (seven of the 325 underwent one), with accuracy ranges from 91-100%.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield. The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to 7 days after injury,” the authors wrote.

For related information, see the Psychiatric News article “Simple Method May Predict Recovery From Concussion.”

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