Better Oversight, Research Needed to Realize Potential of Digital Technologies

Trust and transparency—they are what is missing from the burgeoning market for digital mental health applications, psychiatrists John Torous, M.D., and Laura Roberts, M.D., wrote in a recent editorial in JAMA Psychiatry. 

More than 10,000 mental health–related smart phone applications are available to download, and that number increases daily, the authors noted, but what’s needed is better market oversight and research to help the public to better understand which apps are actually effective (while protecting patient privacy) and which are not. They highlighted the APA App Evaluation Model as an example of what’s necessary to lend trust and transparency to the digital mental health marketplace.

That marketplace is a “wild, wild west,” Torous (pictured above), who is co-chair of the APA App Evaluation Work Group, told Psychiatric News in an interview. “There is tremendous potential for mobile and digital technology to improve psychiatric care and services, but it’s no longer a technology problem,” he said. “The biggest issue we face in the field is trust and transparency. In our editorial, Laura and I are saying that we need to focus less on new, shiny technologies and more on understanding what is useful and what’s not. For that we need to do real research.”

In the absence of oversight and regulation by the Food and Drug Administration (FDA)—which has taken a hands-off approach to regulating digital apps—Torous and Roberts noted that organizations like APA have a role to play. The App Evaluation Model helps clinicians determine “safety, evidence, usability, and interoperability of an application to make a more informed decision about use,” Torous and Roberts wrote.

“Finding the right balance in evaluating and regulating the mobile health space entails a judicious review of evidence and collaboration across diverse stakeholder groups, each bringing their own expertise and experience to bear on a contemporary and socially important issue,” Torous and Roberts added. “Members of the public, patients, clinicians, researchers, policymakers, payers, regulatory bodies like the FDA, and technology companies all have an important voice. These efforts should accelerate innovation and support a healthy, transparent, and trustworthy applications marketplace and progress toward realizing the true potential of these digital technologies.”

For more information, see the Psychiatric News article “APA to Provide Framework to Evaluate Mobile Health Apps” and the Psychiatric Services article “Three Problems With Current Digital Mental Health Research ... and Three Things We Can Do About Them.”

Information on Your MIPS Participation Status Is Coming Soon; Here’s Help

The more than 33,0000 psychiatrists who see Medicare Part B patients will soon learn if they are subject to (or exempt from) Medicare’s new Merit-Based Incentive Payment System (MIPS). The MIPS program, along with incentives for “Advanced” Alternative Payment Models (APMs), together make up the new Medicare Quality Payment Program (QPP). The QPP replaces the Physician Quality Reporting System (PQRS), Meaningful Use (MU) for EHRs, and the Value-Based Payment Modifier (VM).

The Centers for Medicare and Medicaid Services (CMS) is now reviewing past Part B claims to see which practices and which physicians fall within the MIPS “low-volume threshold.” Practices billing no more than $30,000 in Medicare Part B allowed charges per year—or providing care for no more than 100 Part B enrolled beneficiaries—will be exempt from MIPS reporting for 2017. They will also be exempt from MIPS payment adjustments in 2019.  

Beginning later this month through May, each practice will receive a letter from the Medicare Administrative Contractor that processes Medicare Part B claims in its area. This letter will clarify the MIPS participation (or exemption) status for each MIPS “eligible clinician” (physician, physician assistant, or advanced practice nurse) associated with the Taxpayer Identification Number (TIN) for that practice.  

• CMS has estimated that 49% (16,521) of the 33,632 psychiatrists whose services are paid under Part B will qualify for the low-volume exemption.  
• Another 3,000 psychiatrists may be exempt because they just enrolled in Medicare this year (that is, for the first time) or they participate in an “Advanced” APM.

Psychiatrists subject to MIPS reporting requirements can still avoid a penalty with very little time and effort. Under this year’s “Pick Your Pace” transitional approach, all that is required to avoid MIPS penalties in 2019 is simply doing one of the following:  

• Report one MIPS quality measure for one patient.
• Report one MIPS Improvement Activity.

Reporting more complete MIPS data may lead to a MIPS bonus of up to 4%. Also, “exceptional performers” may earn an extra bonus of up to 10%. Future MIPS payment adjustments can be up to 5% in 2020; 7% in 2021; and 9% in 2021 and beyond. In contrast, in 2017, psychiatrists can be subject to penalties totaling 11% under PQRS, MU, and the VM; and up to 12% in 2018.

More Information and Assistance

APA is ready to provide you with the help you need to succeed in the new Quality Payment Program.

• The APA Payment Reform Toolkit has detailed fact sheets and links to recorded webinars about the MIPS program and incentives for “Advanced” APMs.  
• APA members can consult with APA staff experts by sending questions to qualityandpayment@psych.org or calling (800) 343-4671.
• Additional help is available from CMS on the Quality Payment Program website, by email at QPP@cms.hhs.gov, or by phone at (866) 288-8292. 
• To learn about participating in the Quality Payment Program through the APA mental health registry, PsychPRO, go to www.psychiatry.org/registry. 

APA Urges Senate to Confirm McCance-Katz for Asst. Secretary for Mental Health, Substance Use

APA strongly supports the nomination of Elinore McCance-Katz, M.D., Ph.D., to be the first Assistant Secretary for Mental Health and Substance Use in the Department of Health and Human Services and is urging the Senate to swiftly confirm her nomination. 

President Trump announced last Friday that he intends to nominate McCance-Katz, an APA member psychiatrist, to the position. It would be a win for APA, which had been advocating for McCance-Katz’s selection in discussions with the White House. Staff of APA’s Division of Government Relations told Psychiatric News that McCance-Katz brought to the table the skills and experience that the White House—and APA—hoped to see in the position: a strong scientific and medical background with a focus on substance use and experience working at the federal level. 

If confirmed, McCance-Katz would be the first Assistant Secretary for Mental Health and Substance Use and will replace Kana Enomoto, the Acting Assistant Secretary of Health and Human Services. At press time, it was anticipated that the Senate hearing on McCance-Katz’s nomination would take place within the next couple of months. APA members are urged to contact their senators to support her nomination. 

“Dr. McCance-Katz has a wealth of experience in academic and public sector settings in addressing mental health and substance use disorders,” said APA President Maria A. Oquendo, M.D., Ph.D. “She is an accomplished physician, and APA strongly supports her nomination.”

The assistant secretary post was created in the 21st Century Cures Act, a bipartisan bill that passed late last year. The Assistant Secretary is charged with overseeing the Substance Abuse and Mental Health and Services Administration (SAMHSA) and coordinating mental health and substance use programs at other agencies across the federal government. McCance-Katz served in SAMHSA as the first chief medical officer of the agency; her experience there will pay off in her new role, said APA leaders.

“We urge the Senate to confirm Dr. McCance-Katz as soon as possible,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “We look forward to working with her to improve the quality of care of mental health and substance use disorders.”

In a letter delivered today to Senate leaders, Levin and Oquendo emphasized the strengths McCance-Katz would bring to the new position. “To overcome the pervasive opioid addiction in our country, we need a strong leader who can lead the collaboration between primary care and mental health to drive the nation’s recovery,” they wrote. “Dr. McCance-Katz is preeminently qualified to carry out the important responsibilities that need to be undertaken by the Assistant Secretary.”

McCance-Katz is currently the chief medical officer for the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She is also a professor of psychiatry and human behavior and professor of behavioral and social sciences at the Alpert Medical School at Brown University. 

Controlling Elevation of Estradiol, Progesterone May Reduce PMDD Symptoms

Previous studies suggest reproductive steroids play a role in premenstrual dysphoric disorder (PMDD)—a disorder characterized by distressing mood and behavioral symptoms that occur during the luteal phase of the menstrual cycle that disappear shortly after menses begin. It is unclear, however, whether these symptoms are triggered by the rapid rise in hormone levels at the start of this phase or the sustained exposure to elevated hormone levels.

A recent study in AJP in Advance suggests that the changes in estradiol and progesterone levels from low to high trigger the onset of PMDD symptoms. 

“Although the mechanisms underlying the mood-destabilizing effects of ovarian steroids in PMDD remain to be better characterized, as does the source of susceptibility to this trigger, our findings provide a new target for interventions,” Peter Schmidt, M.D., chief of the Section on Behavioral Endocrinology at the National Institute of Mental Health, and colleagues reported.

This discovery came from an assessment of 22 women with PMDD, aged 30 to 50, who were given monthly injections of leuprolide to suppress the production of ovarian hormones. Following two to three months of leuprolide alone, 12 of 22 women reported PMDD symptom remission (as determined by self-reported improvement confirmed by Rating for Premenstrual Tension scale scores <5 and the absence of symptom cyclicity on the Daily Rating Form). Women who responded to leuprolide then received one month of placebo followed by three months of estradiol/progesterone replacement therapy.

The women receiving estradiol/progesterone reported a rise in some PMDD symptoms during the first month of therapy, but there were no significant differences in symptom severity during the subsequent months when plasma levels of these sex hormones were stable, Schmidt and colleagues reported.

“[O]ur findings suggest that there is a ‘half-life’ of the affective state that is triggered, following which it remits,” Schmidt and colleagues wrote. “[T]reatment strategies to attenuate or eliminate the change in estradiol and progesterone (or their metabolites) could effectively target the hormonal trigger in this condition.”

For related information, see the Psychiatric News article “Researchers Uncover Cellular Pathway That May Contribute to PMDD.”

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President Trump Nominates Psychiatrist to Serve as Assistant Secretary of Mental Health

President Donald Trump announced on Friday his intent to nominate Elinore McCance-Katz, M.D., Ph.D., a psychiatrist with a subspecialty in addiction psychiatry, to serve as the Assistant Secretary for Mental Health and Substance Use in the Department of Health and Human Services.

McCance-Katz, M.D., Ph.D., is currently the chief medical officer for the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She is also a professor of psychiatry and human behavior and professor of behavioral and social sciences at the Alpert Medical School at Brown University.

McCance-Katz previously served as the first chief medical officer of the federal government’s Substance Abuse and Mental Health Services Administration (SAMHSA). A long-time member of APA, McCance-Katz led the Physicians' Clinical Support System for Buprenorphine, funded by SAMHSA grants, in collaboration with APA’s Council on Addiction Psychiatry. The program has helped train physicians to prescribe buprenorphine for opioid-dependent patients using distance-learning tools.

“Dr. McCance-Katz possesses a unique blend of academic and public sector experiences squarely focused on mental health and substance use disorders, having served in SAMHSA in the past,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A.

“As an accomplished physician,” said APA President Maria A. Oquendo, M.D., Ph.D., “she will bring a wealth of knowledge in the prevention, treatment, and recovery of substance use disorders which currently challenges the United States. APA strongly supports her appointment.”

McCance-Katz obtained her Ph.D. from Yale University with a specialty in infectious disease epidemiology and is a graduate of the University of Connecticut School of Medicine. She is board certified in general psychiatry and in addiction psychiatry.

Adults With Serious Psychological Distress Are More Likely to Experience Barriers to Care

Adults with serious psychological distress (SPD) face more problems accessing and paying for health care than those without SPD, according to a study published this week in Psychiatric Services in Advance.

Using data from the 2006-2014 National Health Interview Survey conducted by the Centers for Disease Control and Prevention, Judith Weissman, Ph.D., J.D., and colleagues from New York University School of Medicine examined 11 indicators of access, utilization, and function among 207,853 adults. Among the indicators were presence or absence of health insurance coverage, insufficient money for health care and/or medications, delay in health care, insufficient money for health care, visiting a doctor 10 or more times in the past 12 months, limitations in ability to work, limitations in activities of daily living, insufficient money for mental health care, and having seen a mental health care provider.

The researchers found that adults with SPD were significantly more likely than those without SPD to experience barriers to care—including no health coverage, delays in care, lack of money to buy medications and to pay for mental health care services, and change in usual place of health care because of insurance. Although a lack of health coverage and money to buy medications worsened for all adults between 2008 and 2011, the study revealed that the proportion of adults with SPD who lacked money to buy medications continued to climb into 2014.

At the same time, the study found that adults with SPD were more likely than those without SPD to visit a doctor 10 or more times in the past 12 months.

“It is paradoxical that although SPD is associated with several indicators of poor utilization and access, as well as relatively poor general medical health, it is also associated with high utilization of expensive outpatient care,” the authors wrote. “[E]mbedding mental health care providers within the primary care setting and embedding PCPs within the mental health setting … may facilitate better treatment of both mental health and general medical conditions. Moreover, integration of care may reduce chaotic health care utilization, including frequent changes in the location of health care.”

For related information, see the Psychiatric Services article “Characteristics of Individuals With Behavioral Health Conditions Who Remain Uninsured After Full Implementation of the ACA.”

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Patients Taking Psychotropic Medications Found to Be at Elevated Risk of Fractures

Psychotropic medication use increases risk for fractures—a heightened risk that may be missed by a commonly used fracture prediction tool, report the authors of a study published Wednesday in JAMA Psychiatry.

Among adults aged 40 years or older, the study found the risk of a major osteoporotic fracture was 1.43-fold higher in people taking selective serotonin reuptake inhibitors (SSRIs), 1.43-fold higher among people taking antipsychotics, and 1.15-fold higher in people taking benzodiazepines than people not taking these medications. 

“Osteoporosis and mental disorders are highly prevalent conditions, and, as such, these findings have substantial implications for mental health care workers and primary care practitioners,” wrote James Bolton, M.D., of the University of Manitoba (Manitoba, Canada) and colleagues in the paper.

Bolton and colleagues used the Manitoba Bone Density Program database (which contains information on all individuals in the province of Manitoba who have received bone mineral density scans) to assess how mental health influences the risk of major osteoporotic fractures—including hip, arm, and vertebrae fractures. The study cohort included 62,275 women and 6,455 men (average age of 64). Of the 68,730 individuals in the study, 12,982 (18.9%) had been diagnosed with a mental disorder. Psychotropic medication use was recorded in 11,938 (17.4%) of the sample, and 2,468 of these individuals (20.7%) were taking multiple psychotropics. 

The authors found that while a diagnosis of depression, anxiety, or schizophrenia was associated with a higher risk of major osteoporotic fracture, these associations were not significant once adjusted for medication use, suggesting the associations were driven by psychotropic use. Among the medications assessed, SSRIs, antipsychotics, and benzodiazepines increased the risk of both major osteoporotic fractures as a group and hip fractures alone. Tricyclic antidepressants and lithium did not increase the risk of either fracture type, while other antidepressants and mood stabilizers increased overall major osteoporotic fracture risk. 

When the study authors compared the total number of fracture incidents in adults taking psychotropic medications with the expected number based on a common fracture evaluation tool known as FRAX, they found that FRAX significantly underestimated fracture risk in this population. FRAX underestimated the 10-year risk of major osteoporotic fracture risk by 29% for those with depression, by 36% for those exposed to SSRIs, by 63% for those using mood stabilizers, by 60% for those using antipsychotics, and by 13% for those using benzodiazepines. 

“Diagnosed mental disorders and psychotropic medications identify subgroups at increased risk for fractures, and where this excess risk is not fully captured by the FRAX tool,” the authors concluded. “Broader public health initiatives and advocacy may be required to achieve better recognition and management of this elevated risk of fracture given that patients with psychiatric illness may not receive optimal treatment for comorbid physical health conditions.”

For related information, see the Psychiatric News article “Psychotropic Medication and Osteoporosis,” by Sylvia Karasu, M.D.

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Few Child Psychiatrists Follow Guidelines for Metabolic Monitoring of Youth on SGAs

Few child psychiatrists monitor children treated with second-generation antipsychotics (SGAs) in accordance with treatment guidelines, even though most are aware of those guidelines and agree with them, according to a survey published Monday in Psychiatric Services in Advance.

“The low rate of monitoring, despite high levels of awareness of and agreement with the need to monitor, suggests that obstacles interfere with adopting these guidelines,” Jennifer L. McLaren, M.D., of Dartmouth-Hitchcock Medical Center and colleagues wrote. The findings of the survey suggest family resistance to monitoring may be one such barrier to compliance.

Youth treated with SGAs are known to be at a greater risk of weight gain, developing type II diabetes, and elevated cholesterol. In 2004, APA and the American Diabetes Association published guidelines on screening and monitoring of patients on SGAs, which were endorsed by the American Academy of Child and Adolescent Psychiatry (AACAP) in 2011. The guidelines specify routine monitoring of fasting blood glucose, fasting lipid profiles, body mass index (BMI), and abnormal involuntary movements (AIMs) prior to and periodically after initiating SGAs.

McLaren and colleagues sent the survey to 4,144 working email addresses of child psychiatrists throughout the United States who were registered members of the AACAP, excluding psychiatrists in training, between December 2012 and February 2013.

Among responders (N=1,314, 32%), over 95% were aware of the guidelines for monitoring children and adolescents on SGAs. Fewer respondents agreed with the recommendations, with agreement rates ranging from 69% for fasting lipids to 80% for glucose, 89% for AIMs, and 91% for BMI monitoring. Less than 20% had adopted and adhered to most guidelines.

Additional analysis revealed that psychiatrists who were in academic practice had greater monitoring of glucose, lipids, BMI, and AIMs. In contrast, a physician’s length of time in practice was inversely related to monitoring glucose, lipids, and BMI. Many of the psychiatrists surveyed (82%) reported that parents who forget to obtain laboratory tests were a barrier to obtaining fasting glucose and lipids. Other commonly cited barriers were parental resistance (52%) and children’s refusal to obtain the tests (63%).

“Potential interventions to improve adoption include education with audit and feedback directed at specific providers who have not adopted recommended monitoring practices, monitoring reminder systems, and family education to improve knowledge and attitudes about monitoring,” the authors wrote.

For related information, see the Psychiatric News article “Recent Rise in Youth on Antipsychotics Raises Concerns Among Experts.”

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APA Joins Medical-Scientific Community in Support of March for Science

APA has joined 24 other medical and scientific organizations in a statement of support for the March for Science taking place Saturday, April 22, in Washington, D.C., and in other cities around the country.

APA and the other groups said support of scientific education and research is vital. “As the world's leading organizations representing clinicians, laboratory researchers, and physician-scientists committed to improving patient care, we support the March for Science and its nonpartisan call for the appreciation of scientific evidence, education, and investment,” the groups state. “Science has no political agenda but gives us the tools to find the truths about our world and then implement informed policies to enrich our communities.

“Science is vital to our health, as an understanding of human biology is essential to stimulating discoveries that lead to cures for diseases. Every day, physicians make the best patient-care decisions they can by relying on science-based tools. Clinicians prevent disease by administering immunizations, and they manage disease by providing therapies that have been thoroughly and scientifically vetted for optimal outcomes. This science-based care saves lives, decreases human suffering, and reduces unnecessary costs.

“Therefore, it is critical that we protect federal investment in our health. Over the past several decades, research supported by the National Institutes of Health (NIH) has yielded significant advances across all fields of medicine. Today, diseases with previously grim prognoses are treatable. We have powerful therapies that engage the patient’s own immune system to conquer cancers and non-malignant diseases. And, genome editing is showing early promise in curing and even preventing debilitating genetic conditions.

“We rely on evidence from the [federal] Agency for Healthcare Research and Quality to address patient safety, quality of care, efficiency, and access in our health care system. Research supported by the agency has prevented the spread of infections in hospitals and improved access to health care for patients in rural areas. And, through its surveillance programs, the Centers for Disease Control and Prevention (CDC) has played an important role in preventing and controlling inherited and communicable disease as well as dangerous outbreaks. Without the CDC, outbreaks would spread, food-borne illness would go undetected, and chronic diseases would have a higher human and monetary cost.”

The statement concludes, “We hope patients, their families, and everyone committed to advancing health care will join us in celebrating the value of scientific evidence in our everyday lives.”

The text of the group statement and a list of all signatories is posted on the website of the American Hematology Association.

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‘Power’ Approach Gives Patients Stronger Voice in Their Treatment

Psychiatric providers often struggle to blend person-centered care with shared decision making in community clinic settings. “Power statements” is a new approach that may help patients communicate specific goals and participate in their treatment by writing simple, concise sentences, according to new research.

An exploratory study, “Enhancing Clients’ Communication Regarding Goals for Using Psychiatric Medication,” published April 3 in Psychiatric Services in Advance, describes the power statement method and analyses the statements to pinpoint patients’ goals for using psychiatric medications. The lead author is psychologist Patricia E. Deegan, Ph.D., of Pat Deegan & Associates, Byfield, Mass.

More than 17,000 adults with serious mental illness at 69 public mental health clinics were given the option of developing their own power statements. Nearly 14,000 (79 percent) chose to comply. A total of 277 statements were used for content analysis. The majority (51) percent wrote that their personal goal of taking psychiatric medications was to enhance relationships, well-being (32 percent), self-sufficiency (23 percent), employment (19 percent), hobbies (15 percent), and self-improvement (10 percent).

Power statements are part of CommonGround, a Web application that enables people with serious mental illness to participate in treatment decision making and supports their recovery. Power statements also help psychiatric providers understand clients’ goals from the beginning of treatment. These goals can help define treatment success, according to Deegan and colleagues. Patients created power statements in the clinics by using a worksheet that guides users in filling out a two-part template: “I want you to help me find a medication that will help me … so that I can … .”

When patients are empowered to communicate this way, they can express diverse and very personal goals for using medication that extend beyond symptom management, according to the researchers. For most patients, using medication to control symptoms is not an end but a means to an end that includes improved relationships, work prospects, and other parts of a meaningful life, they wrote.

CommonGround was developed by Deegan and contributed financial assistance for this study.

A related AJP in Advance study on the impact of shared decision making with patients is “Effects of Patient Preferences on Outcomes in the Predictors of Remission in Depression to Individual and Combined Treatments (PReDICT) Study.”

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Neurofeedback Using fMRI Found to Decrease MDD Symptoms, Study Shows

Functional magnetic resonance imaging (rtfMRI) providing imaging feedback in real time to patients with major depressive disorder helped them retrieve positive autobiographical memories, increased hemodynamic activity in the amygdala, and decreased depressive symptoms one week after the intervention.

In a report appearing today in AJP in Advance, Kymberly Young, Ph.D., of the University of Pittsburgh and colleagues wrote that in addition to offering a novel clinical intervention for depression, the findings support the role of blunted amygdala hemodynamic reactivity to positive stimuli in depressed patients.

“This neurofeedback intervention targets a specific fundamental mechanism identified by neuroimaging research (blunted amygdala activity during positive memory recall), it appears safe and well tolerated, and it gives patients a sense of control over their treatment and symptom improvement,” according to Young and colleagues.

In the study, 36 patients with MDD were randomly assigned to receive rtfMRI of one of two regions in the brain—the left amygdala (the intervention group; n=19), which is associated with emotion regulation and memory retrieval; and the intraparietal sulcus (the control group; n=17), which is not associated with emotion regulation or memory retrieval. While attempting to mentally retrieve positive autobiographical memories, the subjects were fed back an image representing the level of hemodynamic activation in the target area.

The primary outcome measure was change in score on the Montgomery-Åsberg Depression Rating Scale (MADRS).

Twelve participants in the experimental group responded to neurofeedback, defined as at least a 50 percent decrease in MADRS score, compared with two participants in the control group. Six participants in the experimental group and one in the control group met criteria for remission at study end (MADRS score <10). Moreover, statistical analysis showed that MADRS scores were significantly associated with hemodynamic activation in the amygdala among patients receiving the intervention.

“This novel intervention therefore merits further testing as a potential treatment for depression, and it can serve as a model for novel neuroscience-based interventions,” the researchers concluded.

For related information, see the Psychiatric News article "New Uses of Brain Imaging Get Closer to Clinic."

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Family-Based Therapy May Increase Recovery in Children With Depression

Participating in family-based therapy may offer some children with depressive symptoms an advantage over one-on-one therapy, suggests a study in the Journal of the American Academy of Child and Adolescent Psychiatry. While the study found that children participating in individual supportive psychotherapy (IP) and family-focused treatment both experienced significant improvements, those participating in family-based treatment showed higher rates of recovery.  

“During this period of development, a strategy that formally integrates the family within treatment and provides specific and tailored skills and strategies for managing stress could have some advantage over a less structured, supportive approach,” Martha Tompson, Ph.D., of Boston University and colleagues wrote.

Family-focused treatment for child depression (FFT-CD) aims to assist families in developing skills to combat depression in their child. The technique incorporates several strategies to foster positive and supportive parent-child interactions as well as techniques aimed at boosting skills for communication, coping with stress, and regulating emotions. 

For the study, Tompson and colleagues randomly assigned 134 youth aged 7 to 14 who had a diagnosis of major depressive disorder, dysthymic disorder, or depressive disorder–not otherwise specified to receive 15 sessions of IP or FFT-CD over four months. Children who had thought, conduct, or other disturbances that would interfere with participation (like psychotic disorders, severe obsessive-compulsive disorder, or active substance use disorder) were excluded.

After four months, children in the FFT-CD group showed a higher rate of clinical depression response (at least a 50% decrease in their Children’s Depression Rating Scale–Revised score) than the IP group (77.7% versus 59.9%, respectively). Parents also reported that the FFT-CD helped them better understand their child’s depression and manage it at home.

Both treatments were similar in the other outcomes, which included the reductions in depressive symptom scores over time and overall parent/child satisfaction with the intervention.

“Overall, our findings emphasize the value of psychosocial interventions in the treatment of depressive disorders in childhood,” Tompson and colleagues concluded. 

To read more about family-focused therapies, see the Psychiatric News article “Family-Based Intervention May Help Prevent Anxiety Disorders in Children.”

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FDA Approves First Medication to Treat Tardive Dyskinesia

The Food and Drug Administration on Tuesday announced it approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia (TD)—a serious side effect associated with chronic use of antipsychotics. Ingrezza, a novel and highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product for this condition.

“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”

The approval of the medication was based in part on the results of a study recently published in AJP in Advance, which compared changes in involuntary movements in patients with moderate-to-severe TD who took valbenazine (40 mg/day or 80 mg/day) or with those taking placebo daily for six weeks. Approximately 65% of participants had schizophrenia or schizoaffective disorder, and 85.5% were receiving concomitant antipsychotics.

The authors found that treatment with valbenazine resulted in a significant reduction in patients’ Abnormal Involuntary Movement Scale (AIMS) dyskinesia score compared with placebo. The percentage of participants who achieved at least a 50% reduction in AIMS was 40 percent (p<0.001) in participants receiving 80 mg/day of Ingrezza compared with only 8.7% of those who received placebo.

The FDA announcement described several side effects that could arise from taking the medication: “Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation). Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval. Those taking Ingrezza should not drive or operate heavy machinery or do other dangerous activities until it is known how the drug affects them.”

The medication could be available through a select pharmacy network as early as next week, according to a press release by Neurocrine Biosciences, the developer of Ingrezza. Additional prescribing information is posted here.

For more information, see the Psychiatric News PsychoPharm article “New Hope for Patients With Tardive Dyskinesia” by Stanley N. Caroff, M.D.

White Paper Offers Recommendations for Expanding Clozapine Use

To reduce barriers to clozapine use, prescribers should collaborate with primary care physicians to manage side effects of the treatment that could arise in patients with schizophrenia.

This was one of several recommendations outlined in a recent white paper addressing the underuse of clozapine—an antipsychotic that remains underprescribed, despite its proven efficacy for the treatment of refractory schizophrenia.

“Our report provides recommendations to different key stakeholders about what they should be doing at a minimum,” said co-author Deanna Kelly, Pharm. D. (pictured above), of the Maryland Psychiatric Research Center. “The barriers to use are related to side effects associated with the drug and a lack of provider education. If everyone plays their part, these barriers are not as significant as they may seem. If access to clozapine is improved, millions of patients could benefit. In turn, their improved care would result in substantial cost savings to the entire health care system,” she told Psychiatric News.

Among other recommendations, which were presented at the International Congress on Schizophrenia Research in San Diego last month, were the following:

• All acute care and psychiatric hospitals should have clozapine on their formularies as an essential medication and have policies and procedures to facilitate its safe and appropriate use.
• Psychiatric residency programs should consider including didactic instruction on the use of clozapine and participation in interdisciplinary teams that manage patients on clozapine.
• Clozapine should be a preferred medication on the pharmacy drug lists of all state Medicaid programs and pharmacy benefit/managed care programs contracting with state Medicaid programs, and on the formularies of Medicare prescription drug programs and other payers of pharmacy benefits.
• Academic centers, in consultation with state or local mental health authorities, should encourage interdisciplinary consultation centers for community providers such as psychiatric pharmacists or nurse practitioners involved in the management of patients receiving clozapine.

For more coverage of this topic, see an upcoming edition of Psychiatric News. For related information, see the American Journal of Psychiatry article “Comparative Effectiveness of Clozapine and Standard Antipsychotic Treatment in Adults With Schizophrenia” and the Psychiatric Services article “The Business Case for Expanded Clozapine Utilization.”

Benzodiazepine Use in Alzheimer's Patients Increases Pneumonia Risk

Patients with Alzheimer’s disease who take benzodiazepines are nearly 30% more likely to develop pneumonia than those not taking the medications—a risk that appears greatest during the first 30 days of treatment, reports a study published today in the Canadian Medical Association Journal. 

“Although our findings need further research and confirmation, the increased risk of pneumonia should be considered when benzodiazepines and Z-drugs are prescribed to older adults with Alzheimer disease,” Heidi Tapale, Ph.D., of the University of Eastern Finland and colleagues wrote. Pneumonia is one of the leading causes of death in older adults with Alzheimer’s.

Tapale and colleagues analyzed national registry data on 49,484 community-dwelling adults diagnosed with Alzheimer’s disease between 2005 and 2011. 

In this group, there were 5,232 people taking benzodiazepines (diazepam, nitrazepam, chlordiazepoxide, clobazam, oxazepam, alprazolam, lorazepam, and temazepam) and 3,269 taking related Z-drugs (zopiclone and zolpidem). These patients were matched with an equal number of people with Alzheimer’s not taking either medication.

The researchers then evaluated the effect of incident benzodiazepine use on pneumonia risk, both as an overall risk and time-dependent risk based on duration of medication use—30 days or less, 31 to 180 days, 181 to 365 days, 366 to 1,095 days, and more than 1,095 days. As a secondary analysis, they analyzed benzodiazepine use and risks of extended hospital stays (90 days or more) or death due to causes other than pneumonia. 

Collectively, patients taking either benzodiazepines or Z-drugs had about a 1.22-fold increased risk of developing pneumonia. When analyzed separately, benzodiazepine use was significantly associated with an increased risk of pneumonia (hazard ratio [HR]=1.28), whereas Z-drug use did not confer any increased risk. Among those who were taking benzodiazepines, the increased risk was only observed during the first 30 days of use (HR=2.09). By comparison, benzodiazepine use increased the risk of hospitalization or non-pneumonia death by 1.13 fold. 

“One possible explanation for the increased risk of pneumonia associated with benzodiazepine use may be related to the more pronounced sedative effects of these drugs in this population. Sedation may increase risk of aspiration, which may lead to pneumonia. In addition, sedation is more pronounced at the start of use before tolerance develops,” Tapale and colleagues wrote. 

“However,” they cautioned, “the results are not sufficient to support a conclusion that Z-drugs would be safer than benzodiazepines for patients with Alzheimer disease, because our study was not designed for a direct comparison of the these groups. … Accumulating evidence that use of benzodiazepines and Z-drugs is associated with respiratory adverse effects suggests that future studies examine the possible pharmacologic mechanisms.” 

For related information, see the Psychiatric News article “Geriatric Psychiatrists List Do’s, Don’ts for Treating Behavioral Disturbances Associated with Dementia.”

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High Mortality Rate Found in Youth Newly Diagnosed With Psychosis

Young patients who have been diagnosed with first-episode psychosis (FEP) are much more likely to die within a year of diagnosis than their age-matched peers—in fact, at least 24 times greater, according to a study published April 6 online by Schizophrenia Bulletin.

The findings suggest that youth experiencing psychosis should receive immediate and effective clinical attention, which is often lacking in their follow-up.

Michael Schoenbaum, Ph.D., senior advisor for mental health services, epidemiology, and economics at the National Institute of Mental Health, and his team used health insurance claims data and information from the Social Security Administration to assess the 12-month health outcomes in a group of 5,488 insured young adults aged 16 to 30 years who received a diagnosis of FEP. The researchers examined patterns of outpatient and inpatient treatment, emergency department visits, and all-cause deaths in the study group.

Using the most conservative assumptions, the researchers calculated an all-cause death rate of 1,968 per 100,000 of the cohort, a rate seen only in people aged 70 and over in the general population. In addition, 62% of the cohort had at least one hospitalization and/or one emergency department visit during the initial year of care; 61% did not fill any antipsychotic prescriptions; and 41% did not receive psychotherapy.

“Given accumulating evidence associating timely FEP treatment with positive clinical, social, and employment outcomes, the present findings reinforce the need for widely available coordinated specialty care programs and strategies to provide them as early in after psychosis onset as possible,” Schoenbaum and colleagues wrote. “Such programs are needed to improve outcomes for people experiencing FEP and might help mitigate the extraordinarily high rates of mortality observed in this vulnerable population.”

For related information, see the Psychiatric News article “Early Intervention Trial in Youth at Risk for Psychosis Shows Improved Symptoms” and the Psychiatric Services article “Systematic Review of Integrated General Medical and Psychiatric Self-Management Interventions for Adults With Serious Mental Illness.”

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Researchers Develop Brief Adult ADHD Rating Scale Using DSM-5 Criteria

Researchers have developed an updated screening scale for diagnosing adults with attention-deficit/hyperactivity disorder (ADHD) that is based on DSM-5 criteria. In a report published yesterday in JAMA Psychiatry, Ronald Kessler, Ph.D., of the Department of Health Care Policy at Harvard Medical School and colleagues described the ability of the six-question screen to detect the majority of adults with ADHD, including among patients who present at specialty clinics.

The team of researchers used a machine-learning algorithm to identify an optimal set of screening questions using the World Health Organization Adult ADHD Self-Report Scale (ASRS) as a guide. The final scale included just six questions, including two that are not directly related to DSM-5 symptoms:

• How often do you have difficulty concentrating on what people say to you, even when they are speaking to you directly? (DSM-5 A1c)


• How often do you leave your seat in meetings or other situations in which you are expected to remain seated? (DSM-5 A2b)


• How often do you have difficulty unwinding and relaxing when you have time to yourself? (DSM-5 A2d)


• When you’re in a conversation, how often do you find yourself finishing the sentences of people you are talking to before they finish them themselves? (DSM-5 A2g)


• How often do you put things off until the last minute? (Non-DSM)


• How often to you depend on others to keep your life in order and attend to details? (Non-DSM)

Adults were asked to report how often the symptoms in question occurred over the last six months: never (0), rarely (1), sometimes (2), often (3), and very often (4).

The diagnoses made using the six-question screen were compared with those captured with the ASRS screen, as reflected in two national surveys. The results of the screen were also evaluated in a clinical sample of patients that included a subset who sought evaluations at New York University Langone Medical Center Adult ADHD Program.

When using a cutoff of 14 or higher for the total score, the test identified more than 90% of true ADHD cases in both groups of people, with total accuracy ratings (when including false positives and false negatives) of 67.3% in the general population and 82.8% in the clinical population.   

“The new scale is short, easily scored, can detect nearly all of adult ADHD cases in the general population with high sensitivity and specificity, and also discriminates well among patients presenting for evaluation and specialty treatment,” the authors concluded.

In a related editorial, Judith Rappaport, M.D., of the National Institute of Mental Health and colleagues wrote, “As public awareness of adult ADHD increases, so too does the need for psychometrically robust screening tools both for research and to help identify those most likely to benefit from further expert assessment and treatment.”

To read more about this topic, see the Psychiatric News article “Study Suggests ADHD in Adults May Be Distinct Disorder.”

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Interpersonal Therapy for PTSD Effective for Patients With History of Sexual Trauma

Patients who have a history of sexual trauma may be more likely to respond to interpersonal psychotherapy for posttraumatic stress disorder (PTSD) than other common psychotherapies, according to a study published yesterday in Depression and Anxiety. The findings suggest that helping patients to build trust in the aftermath of a trauma may be particularly beneficial for patients who have been victims of sexual assault.

John C. Markowitz, M.D., a research psychiatrist at the New York State Psychiatric Institute, and colleagues compared the outcomes of 110 unmedicated patients who had chronic PTSD and a score >50 on the Clinician-Administered PTSD Scale (CAPS) and were assigned to three different types of therapy over a 14-week period: weekly interpersonal psychotherapy (IPT), prolonged exposure (PE: standard, reference treatment), or relaxation therapy (RT: active control condition). 

As was previously reported in the American Journal of Psychiatry, the authors found IPT had a higher response rate (defined as >30% CAPS reduction) than RT (63% vs. 38%), and nonsignificantly lower dropout than competing treatments (IPT=15%, PE=29%, RT=34%). Among patients with comorbid major depressive disorder (MDD)—50% overall—PE dropout trended higher than in IPT.

Thirty-nine (35%) patients in the trial reported sexual trauma, 68 (62%) reported physical trauma, and 102 (93%) interpersonal trauma. Baseline CAPS scores did not differ by the presence or absence of trauma types, the authors noted in the current report. “Although all therapies had equal efficacy among patients without sexual trauma, sexually traumatized patients [had less positive outcomes] in PE and RT than in IPT,” they wrote.

Markowitz, who is also a professor of clinical psychiatry at Columbia University College of Physicians and Surgeons, told Psychiatric News that the findings suggest an advantage of IPT over PE for patients with sexual trauma. “Together, these findings hint at differential therapeutics: when to recommend one treatment over another for a given patient,” he said.

For related information, see the Psychiatric News article “Human Trafficking Should Be on Psychiatrists’ Radar.”

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Persistent Hallucinations May Increase Risk of Multiple Mental Health Disorders

While more than 12% of youth report having experienced a hallucination, these hallucinations are often transitory and do not indicate that later onset of psychosis is inevitable. However, youth who experience multiple hallucinations may be at a heightened risk of a variety of mental illnesses—not only psychosis—and suicide later in life.

Those were among the takeaway messages offered by several speakers at the International Congress of Schizophrenia Research (ICOSR) in San Diego last month.

James Scott, M.D., an affiliate associate professor at the University of Queensland Centre for Clinical Research, Australia, reported results from an Australian birth cohort study that included data on the mental health outcomes of individuals aged 30 to 33 who had filled out the Youth Self-Report Questionnaire at ages 14 and 21.

A total of 455 participants (12.9% of the total sample) self-reported having hallucinations at age 14, but not at age 21, and 140 (4%) self-reported hallucinations at both 14 and 21 years of age. These data were compared with those from 490 controls who reported no history of hallucinations at either time point.

Those with hallucinations at both 14 and 21 years had close to nine times the odds of having a psychotic disorder by 30 years of age compared with controls. Those with persistent hallucinations were also 2.3 times more likely than controls to have a substance use disorder and 3.6 times more likely to have an eating disorder. Moreover, those who reported a history of hallucinations at both time points had more than seven times the risk of any lifetime suicide attempt compared with controls. They were also less likely to be employed or in job training and four times as likely to have a poor quality of life, Scott reported.

Scott said that adolescents who present with hallucinations should receive a thorough mental health assessment, including screening for the presence of current or past trauma, suicidal ideation, and substance use. Avoidance of substance use, especially cannabis, is critical, Scott said. “Most adolescents who experience hallucination are not going to progress to psychosis, and most don’t develop schizophrenia. But it’s really important to avoid cannabis use.”

Look for further coverage of ICOSR in coming editions of Psychiatric News. For related information, see the AJP article “Personalized Prediction of Psychosis: External Validation of the NAPLS-2 Psychosis Risk Calculator With the EDIPPP Project.”

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Adjunctive VNS Improves Long-Term Outcomes in Treatment-Resistant Depression

Adjunctive vagus nerve stimulation (VNS) can lead to better five-year clinical outcomes in patients with chronic, treatment-resistant depression, reports a study published March 31 in AJP in Advance.

These findings provide the first long-term evidence of the benefits of VNS.

VNS, which involves delivering electrical impulses to the vagus nerve via an implanted generator, was approved for treatment-resistant depression in 2005. As part of the approval, the Food and Drug Administration required a postmarketing surveillance study, which led to the formation of the Treatment-Resistant Depression Registry. The registry is an observational program carried out at 61 sites across the United States that has monitored a large cohort of patients with treatment-resistant depression for five years each.

There were 795 study participants. Treatment resistance was defined as ongoing unipolar or bipolar depression that lasted at least two years or recurred at least three times and failure on four or more depression treatments, including maintenance pharmacotherapy, psychotherapy, and ECT. Within the group, 494 patients received periodic VNS over five years in addition to usual treatments, and 301 received usual-treatment only.

The Montgomery-Åsberg Depression Rating Scale score was used to assess clinical outcomes, with response defined as a decrease of 50% or more from a patient’s baseline score, and remission defined as achieving a MADRS score of 9 or less.

The patients in the VNS group showed a five-year cumulative response rate of 67.6%, which was significantly higher than the 40.9% response rate in the usual-treatment group. Compared with treatment as usual, patients receiving VNS also had a shorter time of first response (12 months vs. 48 months) and a higher remission rate (43.3% vs. 25.7%).

“The improved outcomes with adjunctive VNS observed for both ECT responders and nonresponders is remarkable,” the study authors wrote. “For patients who respond to ECT―who often rely on maintenance ECT or additional courses of life-disrupting treatment with ECT―VNS may provide a tolerable alternative, and for patients who do not respond to ECT―for whom psychiatric care offers limited therapeutic options―VNS demonstrates significant efficacy.”

To read more about neuromodulation, see the Psychiatric News article, “Neuromodulation May Offer New Option for Patients with Psychiatric Disorders.”

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