Wednesday, March 22, 2017

Suicide Risk After Violent Attempt Found to Be Highest Within First 30 Days

An article published yesterday in AJP in Advance suggests that people who survive violent self-harm events, particularly those involving self-inflicted firearm injuries, are at the greatest risk of suicide in the 30 days following an initial self-harm event. 

“Adults who present for treatment after a deliberate self-harm event offer opportunities for suicide prevention,” Mark Olfson, M.D., M.P.H., and colleagues wrote. “[C]linical priority should be given to developing and implementing prompt interventions that help ensure the safety of these high-risk patients during this high-risk period.”

For the study, Olfson and colleagues extracted Medicaid data on adults aged 18 to 64 with clinical diagnoses of deliberate self-harm (n=61,297). The self-harm cohort was followed forward from the index date for 365 days, date of death from any cause, or end of available data, whichever came first. A total of 243 deaths by suicide took place during the follow-up period.

The researchers reported that during the first year following the index self-harm event, the suicide rate for the follow-up cohort was 439.1 per 100,000 person-years—37 times greater than the suicide rate of the U.S. general population (11.8 per 100,000 person-years). Additional analysis revealed that self-harm patients who survived previous violent self-harm events as well as those who were male and older were at an elevated risk of suicide. Self-harm patients who used violent methods were at significantly increased risk of suicide during the first 30 days after the initial event compared with those who used nonviolent methods (hazard ratio=17.5, 95%; CI=11.2–27.3), but not during the following 335 days.

“This risk pattern supports concerted efforts to protect patients who attempt suicide by highly lethal methods during the acute period after the self-harm event. During periods of extremely high risk, inpatient admission may facilitate crisis work, intensive supervision, and implementation of complex interventions, and it can help ensure patient safety,” the authors wrote. “For patients who own firearms or live in homes with firearms, distributing trigger locks and urging family members to temporarily store household firearms away from the patient’s home can be a lifesaving intervention.”

For related information, see the Psychiatric News article “Firearms and Suicide: Risk Assessment and Management” and The Return on Investment of Postdischarge Follow-Up Calls for Suicidal Ideation or Deliberate Self-Harm.

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Tuesday, March 21, 2017

Valbenazine Found to Reduce Symptoms of Tardive Dyskinesia in Patients With Schizophrenia

Once-daily treatment with valbenazine (NBI-98854), a highly selective vesicular monoamine transport 2 (VMAT2) inhibitor, significantly reduced the symptoms of tardive dyskinesia (TD) compared with placebo in patients with schizophrenia, schizoaffective disorder, or a mood disorder, according to a study published today in AJP in Advance. The findings suggest the VMAT2 inhibitor, developed by Neurocrine Biosciences Inc., may be an effective treatment option for patients experiencing the involuntary, repetitive body movements associated with the disorder.

Research shows that approximately 1 in 4 patients with chronic exposure to antipsychotics develops TD. While there are several strategies for managing TD, to date no medications have been approved by the Food and Drug Administration (FDA) for the treatment of TD.

For the study, Robert Hauser, M.D., M.B.A., of the University of South Florida and colleagues randomly assigned 234 patients with schizophrenia, schizoaffective disorder, or a mood disorder to take valbenazine (40 mg/day or 80 mg/day) or placebo daily for six weeks. All patients in the trial had moderate-to-severe TD at screening, and approximately 85% were also taking antipsychotics throughout the trial. The researchers compared change from baseline in dyskinesia scores on the Abnormal Involuntary Movement Scale (AIMS, items 1–7) at two, four, and six weeks.

A total of 205 patients completed the study. The mean change from baseline to week six of the AIMS dyskinesia score was −3.2 for the 80 mg/day group, compared with −0.1 for the placebo group, a significant difference. The mean AIMS dyskinesia score was also reduced in the 40 mg/day group (−1.9 compared with −0.1). Valbenazine was generally well tolerated, with somnolence, akathisia, and dry mouth reported by 5.3%, 3.3%, and 3.3% of patients in both dosage groups, respectively.

“These findings add to a growing body of evidence showing that valbenazine is effective … at reducing the severity of movements in patients with moderate-to-severe TD,” said Stanley Caroff, M.D., an emeritus professor of psychiatry at the Perelman School of Medicine at the University of Pennsylvania, who not involved with the study. “Although many fundamental questions remain—including concurrent changes in antipsychotic and anticholinergic therapy, the course and outcome of TD in long-term investigations, and relative costs of treating TD—the availability of an agent that significantly suppresses manifestations of TD would be extremely valuable in reducing the stigma and embarrassment that accompanies TD, thereby enhancing social rehabilitation and recovery efforts," Caroff concluded.

In 2016, Neurocrine announced that the FDA was reviewing the company’s New Drug Application (NDA) for valbenazine for the treatment of TD. According to a press release by the company, the FDA is expected to reach a decision by April 11, 2017.

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

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Monday, March 20, 2017

5α-Reductase Inhibitors May Increase Risk of Self-Harm, Depression in Older Men

Although the 5α-reductase inhibitors (5ARIs) finasteride or dutasteride are known to lead to improvements in men with benign prostatic hyperplasia (BPH), postmarketing data have suggested that men taking the medications might be at a greater risk of suicide and self-harm. A study published today in JAMA Internal Medicine has found that men 66 and older who took 5ARIs were not at a significantly increased risk of suicide. However, the risk of self-harm and depression in men taking these medications increased during the first 18 months of use compared with men not exposed to the medications. 

“The recognition of depression and self-harm as potential adverse effects of 5ARIs is important given their significant impact. However, the relatively small magnitude of these risks should not dissuade physicians from prescribing these medications in appropriate patients,” Blayne Welk, M.D., an assistant professor of surgery at Western University in London, Ontario, and colleagues wrote. “This research may help physicians counsel patients on the risks of 5ARIs.”

Belk and colleagues compared administrative data available for 93,197 men aged 66 and older in Ontario who started taking a 5ARI between 2003 and 2013 with an equal number of older men not prescribed these medications. During the study period, there were a total of 38 suicides, 169 incidents of self-harm, and 1,750 cases of depression among the participants taking a 5ARI. 

There was no difference in suicide risk between the groups, but among men exposed to 5ARIs, there was a significantly increased risk of self-harm (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.34-2.64) during the first 18 months of use; this risk of self-harm did not remain significantly elevated after the initial 18 months. There was also a significantly increased risk of depression (HR=1.94; 95% CI=1.73-2.16) during the first 18 months of use, and this risk continued to be elevated after 18 months, though to a lesser degree (HR=1.22; 95% CI=1.08-1.37). Men taking finasteride or dutasteride appeared to be at similar risk of suicide, self-harm, and depression.

Because the absolute risk of self-harm and depression was found to be low, the researchers noted “the potential benefits of 5ARIs in this population likely outweigh these risks for most patients. … Discontinuation of the 5ARI may be appropriate in the setting of new-onset depression or self-harm after the initiation of a 5ARI.”

The authors noted that additional studies are needed to determine the risk of suicide, self-harm, and depression in younger men prescribed finasteride for hair loss.

For related information, see the Psychiatric News article “Large Trial Suggests Testosterone Offers Moderate Benefits.”

(Image: Diego Cervo/Shutterstock)

Friday, March 17, 2017

Rural Suicide Rates Outpaced Urban Rates From 1999 to 2015

Suicide rates in the United States increased steadily between 1999 and 2015, but the rates for less urban counties climbed faster than those for cities, according to a report today from the Centers for Disease Control and Prevention (CDC).

“[T]he gap in rates between less urban and more urban areas widened over time, and rates in medium metro, small metro, and non-metro areas increased at a more rapid pace beginning in 2007–2008,” wrote Scott Kegler, Ph.D., of the CDC’s Division of Analysis, Research, and Practice Integration, and two colleagues in Morbidity and Mortality Weekly Report.

Overall rates rose from an average of 12.6 per 100,000 in 1999-2007 to an average of 14.4 per 100,000 in 2008-2015. However, rates jumped from about 15/100,000 in rural areas in 1999 to about 22/100,000 in 2015. In large central metropolitan areas, the rate went from about 11/100,000 to 12/100,000.

Kegler and colleagues suggested that some of the factors associated with the disparity were shortages of clinicians in less urban areas, as well as limited access to mental health care, social isolation, and the effects of the opioid overdose epidemic and the 2007-2009 economic recession (which struck rural areas especially hard).

“There is a growing need for comprehensive suicide prevention employing a broad public health approach,” they concluded. Besides general anti-suicide strategies, additional help for rural areas might include increasing the number of health care providers through incentives, expanding the use of telepsychiatry, and promoting social connectedness.

For more in Psychiatric News about rural suicide prevention, see “Understanding Access to Means of Suicide Opens Door to Prevention.” See also "Preventing Suicide: A Technical Package of Policies, Programs, and Practices" from the CDC.

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Thursday, March 16, 2017

Doctors, MDD Patients Found to Have Different Cost Concerns

Health care costs appear to be a regular topic of conversation between psychiatrists and patients receiving care for major depressive disorder (MDD), occurring in more than one in three visits, according to a study published today in Psychiatric Services in Advance. The study found psychiatrists may be more likely to initiate a conversation about the cost of psychotropic medications, while patients may be more likely to initiate a dialogue about the cost of provider visits.

Gregory Brown, M.D., of Duke University School of Medicine and colleagues relied on content of patient visits sampled from the Verilogue Point-of-Practice database of audio-recorded and transcribed clinical encounters. The researchers focused specifically on visits for medication management in outpatient, private-practice offices across the United States. The researchers considered any mention of a patient’s out-of-pocket expenses or insurance coverage for a past, present, or potential health care service to be a “cost conversation.”

A total of 422 patients with MDD and 36 psychiatrists in clinics across 20 states were included in the study. The researchers found that 38% of visits contained a cost conversation. Cost conversations most commonly addressed medications (n=136 of 208; 65% of all cost conversation topics), and more than half of these conversations dealt specifically with the cost of psychotropic drugs (n=107 of 208; 51%). Nonpharmacologic therapies and services accounted for 35% of cost-conversation topics.

Although rates for initiating cost conversations were similar between psychiatrists and patients, physicians were more likely to initiate conversations about the cost of psychotropic medications than patients (62% versus 38%). In contrast, patients were more likely to initiate conversations about the cost of provider visits (27% versus 10%).

Overall, 45% of cost conversations involved at least one cost-reduction strategy, such as facilitating the use of copay-assistance programs or cost-saving coupons, providing free samples, or switching to a lower-cost therapy or diagnostic test.

“By exploring the frequency and duration of discussions about health care cost in these encounters, as well as the cost-reducing strategies therein, we are able to provide novel insights about the extent to which psychiatrists and patients discuss efforts to manage out-of-pocket health care costs,” wrote Brown and colleagues. “[W]e hope to help psychiatrists recognize the many ways in which they can help patients reduce out-of-pocket expenses.”

For related information, see the Psychiatric News article “Levin Meets With Congressional Leaders About Fate of Affordable Care Act.”

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Wednesday, March 15, 2017

Risk of Premature Death May Be Highest in Year Following Psychiatric Hospital Discharge

Multiple studies have documented the challenges that patients with psychiatric disorders might face after being discharged from inpatient psychiatric services. A study published today in JAMA Psychiatry now finds that the first year following discharge may mark a period of increased risk of premature death from both natural and unnatural causes.

The study highlights the need for clinicians to work together to monitor and support patients shortly after a psychiatric hospitalization discharge. 

“In this national, register-based cohort study of 1,683,385 Danish residents, 48,599 of whom were discharged from inpatient psychiatric care for the first time, the risk of dying prematurely within the first year of discharge was 16 times higher than the risk for those who were not admitted to a psychiatric facility,” Roger T. Webb, Ph.D., of the University of Manchester in England and colleagues wrote. 

Webb and colleagues relied on information contained in Danish registries to identify individuals who experienced their first discharge from an inpatient psychiatric unit or a psychiatric ward in a general hospital from January 1, 1982, through December 31, 2011. The authors then compared causes of death in these patients with the remaining members of the cohort who had not been admitted for inpatient psychiatric services.

Of the 48,599 discharged patients who were included in the study, 25,006 (51.4%) were female, 35,660 (73.4%) were aged 15 to 29 years, and 33,995 (70.0%) had a length of stay of 30 days or less. Compared with people who were not admitted to psychiatric inpatient care, discharged patients were at elevated risk for all types of mortality examined (incidence rate ratio [IRR], 16.2), and their risk of dying from unnatural causes (IRR, 25.0) was considerably higher than dying from natural causes (IRR, 8.6). Patients at a particularly high risk of premature death were those who were admitted involuntarily (IRR, 30.0) and those who were diagnosed with psychoactive substance abuse disorders (IRR, 24.8). 

Across all outcomes examined, the risk of premature death during the first year after discharge was higher than the risk of death after the first year, with suicide representing the greatest differential between short-term (one-year) (IRR, 66.9) and long-term (IRR, 24.2) follow-up.

“For patients hospitalized with psychiatric disorders, the time shortly after discharge is the period in which they are at the highest risk for premature death from a variety of causes. Clinicians should keep these patients safe by serving as a liaison between primary and secondary health care services to ensure patients are receiving holistic care that meets their physical and mental health needs as well as addresses their psychosocial problems,” the authors wrote. “Patients with alcohol and drug use disorders and those admitted involuntary should be monitored particularly closely, interventions targeting substance abuse should be offered to patients at early stages of their treatment, and dedicated care coordinators should provide appropriate levels of clinical surveillance.”

For related information, see the Psychiatric News article “Psychiatric Patients at Highest Suicide Risk Following Hospital Discharge.”

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Tuesday, March 14, 2017

Depression, Posttraumatic Stress Symptoms May Impact Time in Hospital after Injury

The presence of depression and posttraumatic stress symptoms following a traumatic injury may lengthen a hospital stay, according to a report in General Hospital Psychiatry. The results highlight the importance of screening for symptoms of posttraumatic stress and depression upon admission to trauma units and longitudinal monitoring of patients who have experienced traumatic injuries.

“While not all who evidence elevated depression and PTSS [posttraumatic stress symptoms] will meet diagnosis for MDD or PTSD in the months following their injury, those with initially heightened symptoms may be identified as an at-risk group requiring follow-up care,” the study authors wrote.

For the study, a team of researchers from the University of North Texas assessed PTSS and depression symptoms in patients aged 18 or older who had been admitted to a trauma center for a period of at least 24 hours. Patient demographic information, hospitalization characteristics (including the number of complications and total hospital length of stay), and injury-related information (including the type and severity of injury and level of impaired consciousness) were obtained from the hospital trauma registry.

Of the 460 patients included in the analysis, 34.1% tested positive for depression, 31.3% tested positive for PTSS, and 18.3% tested positive for both depression and PTSS.

A comparison of hospital outcomes in patients who tested positive for depression and/or PTSS and those who did not revealed that PTSS and depression were significantly correlated with total hospital length of stay. Both depression-positive and PTSS-positive groups had an average increased hospital length of stay of two days—which the authors noted can add upward of $4,000 to $5,000 to the cost of post-trauma care.

“Being able to identify patients who present with these symptoms and are therefore at an increased risk of longer LOS [length of stay] may help health providers adjust care accordingly. Additionally, early identification may allow for the incorporation of appropriate interventions to increase psychiatric well-being, decrease LOS, and ultimately lead to better physical and mental health outcomes.”

For related information, see the Psychiatric News article “From Just Surviving, ICU Physicians Turn Focus to Survivorship.”

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Monday, March 13, 2017

Online Parenting Program Improves Anxiety Symptoms in Children

A group-based parenting program known as Cool Little Kids has been shown to be an effective intervention to decrease the incidence of anxiety disorders among at-risk children. This face-to-face program provides strategies for parents to help manage their child’s avoidant coping, reduce overprotective behaviors, and encourage child independence.

A study in Journal of the American Academy of Child and Adolescent Psychiatry has now found that an online version of Cool Little Kids can also reduce the symptoms of childhood anxiety and the degree to which anxiety interferes with daily life. The findings suggest that the online parent support program may be able to benefit a greater number children by removing barriers like access to trained therapists and scheduling obstacles without driving up costs.

For the study, Amy Morgan, Ph.D., of La Trobe University in Australia and colleagues recruited 433 parents with a child aged 3 to 6 who was experiencing behavioral distress and social withdrawal (seen as precursors to an anxiety disorder). The parents were randomized to participate in Cool Little Kids Online—which consisted of eight online modules that they could view at their own pace—or be placed on a waitlist. The parents completed self-report questionnaires at the start of the study and then again at 12 and 24 weeks.

After 24 weeks, 40% of the children whose parents were in the intervention group had a diagnosed anxiety disorder compared with 54% in the waitlist group. The diagnoses were based off of parent-reported Online Assessment of Preschool Anxiety scores, which were then reviewed and verified by a clinical psychologist.

The parents participating in Cool Little Kids Online also reported significantly greater improvements in their children’s anxiety symptoms (measured by the Revised Preschool Anxiety Scale) and greater reductions in the negative effects of anxiety on daily life (measured by the preschool version of the Children's Anxiety Life Interference Scale). The two groups did not differ in total child internalizing symptoms or overprotective parenting.

“Online dissemination [of Cool Little Kids] has the potential to reach larger numbers of parents in the community with greater cost-efficiency than face-to-face delivery by trained professionals,” Morgan and colleagues wrote. “Additional research could investigate how to optimize the program in order to maximize its positive impact on anxious children and their families.”

To read more on this topic, see the Psychiatric News article “Family-Based Intervention May Help Prevent Anxiety Disorders in Children.”

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Friday, March 10, 2017

Refusal, Dropout Rates Differ Between Patients Receiving Psychotherapy, Pharmacotherapy

Patients prescribed pharmacotherapy alone to help alleviate the symptoms of psychiatric disorders may be more likely to refuse or prematurely end treatment than those who receive psychotherapy alone, according to a meta-analysis published in the journal Psychotherapy. The authors of the report suggested that these findings point to the importance of considering refusal and dropout rates when making treatment recommendations.

For the study, Joshua Swift, Ph.D., an assistant professor of psychology at Idaho State University, and colleagues analyzed data from 186 studies that compared rates of treatment refusal or premature termination by patients with psychiatric disorders who were assigned to psychotherapy, pharmacotherapy, or a combination of psychotherapy and pharmacotherapy. Of the 186 studies included in the analysis, 57 (6,693 patients) included information on patients who refused treatment recommendations, and 182 (17,891 patients) included information on those who prematurely terminated treatment.

The researchers found that the average refusal rate was 8.2% across all studies. Patients assigned to pharmacotherapy alone were 1.76 times more likely to fail to initiate their treatment than patients who were assigned to psychotherapy alone. Further analyses comparing refusal rates by psychiatric disorder revealed rates of treatment refusal were greatest in patients with panic disorder and depression, who were found to be, respectively, 2.79 and 2.16 times more likely to refuse pharmacotherapy than their condition-matched counterparts who were assigned to psychotherapy.

For patients who began treatment, 21.9% failed to complete the recommended regimen, and those assigned to pharmacotherapy alone were on average 1.20 times more likely to drop out compared with those assigned to psychotherapy. Rates of premature termination were highest in patients with anorexia/bulimia and patients with depression, respectively, who were 2.46 times and 1.26 times more likely to terminate prematurely than their condition-matched counterparts who were assigned to psychotherapy.

“Based on these results, we believe that in addition to considering treatment efficacy, treatment referrers and providers and those who develop treatment guidelines should consider refusal and dropout rates when making treatment recommendations,” wrote Swift and colleagues. “After all, a highly effective treatment can only work if clients are willing to engage in it.”

For related information, see the Psychiatric News article “Motivational Interviewing for Clinical Practice: Just Do It,” by Carla Marienfeld, M.D., of the University of California, San Diego; Bachaar Arnaout, M.D., of Yale School of Medicine; and Petros Levounis, M.D., of Rutgers New Jersey Medical School.

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Thursday, March 9, 2017

Efficacy Data Support Use of SSRIs in Youth, Expert Concludes

The question of whether selective serotonin reuptake inhibitors (SSRIs) should be prescribed to children and adolescents has been a topic of much debate for years—with some meta-analyses suggesting that the medications are minimally effective, not effective, or equivalent to placebo. In a review published in AJP in Advance, child psychiatrist John T. Walkup, M.D., of Weill Cornell Medicine advises clinicians to look more closely at the strengths and weaknesses of the studies being included in meta-analyses when making decisions about prescribing SSRIs for youth.

After describing the scientific and regulatory context for the large number of antidepressant trials in the late 1990s and early 2000s, Walkup noted several key differences between the implementation of industry-supported antidepressant trials in children and adolescents and those funded by the National Institute of Mental Health (NIMH).

He wrote, “The confluence of pressure [in industry-sponsored antidepressant trials] to recruit a large number of participants in a tight time frame, large numbers of sites with small Ns per site, site investigators with unknown pediatric depression or clinical trial experience …, and the inclusion of prepubertal children may have resulted in the inclusion of participants with all forms of unhappiness”—all factors that could contribute to high placebo response rates and low active medication response rates. “The results of the industry-sponsored studies were relatively consistent, with response rates of active drug in the 55%–65% range and placebo response rates in the 50%–60% range. The positive outcomes demonstrated an approximate 8% difference between groups,” he stated.

In contrast to the industry-sponsored trials, Walkup noted that the NIMH studies were “characterized by many methodological strengths, lower placebo response rates (30%−35%), and meaningful between-group differences (25%−30%) that support antidepressant efficacy.”

Walkup suggested that instead of concluding that industry antidepressant trials with high placebo response rates (50%-60%) and small between-group differences (~10%) failed to demonstrate efficacy, such trials should be considered failed trials due to substantial methodological problems—and, as such, should not be included in meta-analyses of efficacy. Such trials “may provide valuable information about safety and tolerability,” he wrote, “but not about efficacy.”

In a related editorial, Daniel S. Pine, M.D., of the NIMH Intramural Research Program and Robert Freedman, M.D., of the University of Colorado Denver Health Sciences Center wrote, “Clearly, SSRIs can have adverse effects on behavior in children and adolescents. Moreover, even in government-funded studies of the highest quality, the magnitude of the clinical effect in major depression is not large. Nevertheless, Walkup reminds us that the efficacy data clearly do support the use of SSRIs in pediatric major depression, anxiety disorders, and OCD and that the benefits outweigh the risks in many clinical scenarios.”

For related information, see the Psychiatric News PsychoPharm article “How Effective Are Antidepressants in Youth?

Clarification: It was reported in yesterday’s Alert that the American Health Care Act would repeal coverage of “essential health benefits” required in plans under the ACA. In fact, the bill calls for the repeal of coverage of essential health benefits in the Medicaid expansion plans but not in the exchange plans for the individual and small group markets.

Wednesday, March 8, 2017

APA Expresses Concerns Over Parts of New Health Care Bill

Two committees of the House of Representatives today began consideration of the American Health Care Act, the Republican mechanism to “repeal and replace” the Affordable Care Act (ACA).

The process will not in fact eliminate the ACA. The current action takes place under complex rules in the House and Senate limited to spending and revenue. This “reconciliation” process requires only a simple majority to pass legislation. To repeal other provisions of the ACA that do not have a direct budgetary impact, the Congress must eventually pass separate legislation that requires a 60-vote majority in the Senate, enough to overcome a filibuster.

“While a number of details about the potential impact of the proposed ACA replacement remain unknown, our current understanding of the proposal raises many concerns for people with mental illness,” said APA President Maria A. Oquendo, M.D., Ph.D., in a statement.

Major changes to Medicaid are particularly worrisome because almost one-third of people receiving coverage through Medicaid expansion have mental health or substance use disorders, noted Oquendo.

The new plan would repeal coverage of “essential health benefits” required in Medicaid expansion plans under the ACA. Such a change would give states the option to end guaranteed treatment for mental health and substance use disorders, thus threatening parity. Other provisions would roll back Medicaid expansion and limit a state’s Medicaid per capita spending.

The law also would eliminate cost-sharing subsidies and the individual mandate to buy insurance, while requiring a 30% surcharge for individuals who have been uninsured for more than 63 days in the preceding 12 months. Such a provision would disproportionately affect low-income individuals and people with mental illness, who are more likely to go without insurance.

The bill retains some valuable provisions of the ACA, like covering preexisting provisions, capping out-of-pocket expenditures, and covering adult children up to age 26.

The legislative process now under way is likely to be complex and contentious, while packed into a compressed work schedule. The House and Senate took more than a year to consider the ACA, but Republican leaders have signaled a desire to move the American Health Care Act through both houses in a matter of weeks.

“APA is committed to working with members of both parties in Congress to help ensure adequate access to quality mental health care for all those in need,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a statement.

For more in Psychiatric News about health care legislation, see The Future of the ACA by APA President Maria A. Oquendo, M.D., Ph.D.

(Image: iStockphoto)

Tuesday, March 7, 2017

FDA Label Changes Found to Play Major Role in Prescribing Patterns

Despite the common practice of off-label prescribing, FDA-approved labeling changes still appear to play a major role in how providers select medications for specific conditions, a study in Psychiatric Services in Advance reports.

Peggy O’Brien, Ph.D., a researcher at Truven Healthy Analytics LLC and colleagues used the National Disease and Therapeutic Index (NDTI) to examine three major categories of psychotropic medications—antidepressants, antipsychotics, and anxiolytics. The NDTI is a survey of more than 4,000 randomly selected, office-based physicians, which specifically asks physicians about the condition for which they prescribed a medication. The authors compared “snapshots” of data collected at two points—in 2005 and 2013.

The analyses showed that many significant changes in the use of a class of drugs for certain indications coincided with labeling changes: the addition of new indications for a class of drugs was associated with increased prescribing, while the addition of black-box warnings and associated side effects were associated with decreased use. For example, the use of antipsychotics for depressive disorders increased from 5.3 percent in 2005 to 13.6 percent in 2013, as numerous antipsychotics gained approval for treating depression. In contrast, prescriptions of antipsychotics for delirium, dementia, and related indications dropped from 7.4 percent in 2005 (the year the FDA announced the boxed warning against this use) to 2.8 percent in 2013. The study also revealed that off-label use of antidepressants for attention-deficit and related disorders and anxiolytics for bipolar disorders increased by 1.1 and 1.3 percentage points, respectively.

O’Brien and colleagues noted that the findings raise questions about the incentives and barriers that influence whether pharmaceutical companies apply for labeling changes related to new indications.

“A number of factors may influence the decision to seek additional labeling for a medication, including whether it is already used off label and, particularly, if it is already [available in] generics,” O’Brien told Psychiatric News. “Each [supplemental] application and the research needed to support it can require considerable resources and expenditures.”

The authors concluded, “These findings highlight that labels are an important but imperfect guide for physicians to make prescribing decisions. … Tracking prescribing for labeled and off-label conditions is a useful tool for illuminating whether new labeled indications may be appropriate, whether research on new indications and contraindicated indications is needed, and whether physicians may benefit from additional education about the application of particular medications for particular clinical scenarios.”

For additional coverage on this report, see the Psychiatric News PsychoPharm article “What’s in a Label?

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Monday, March 6, 2017

International Adoptees Found to Have More Mental Health Problems as Adolescents

International adoptees may experience more mental health problems during adolescence than their non-adopted peers, suggests a meta-analysis appearing in the March issue of the Journal of the American Academy of Child and Adolescent Psychiatry. Although the authors of the report noted that most internationally adopted adolescents are well adjusted, they said the findings emphasize the need “for clinicians to be prepared for adoption to become a theme in therapy and to have knowledge about adoption-specific topics when working with adoptees.”

Researchers at the Norwegian Institute of Public Health analyzed 11 studies, which included 17,919 adoptees aged 12 to 19 and 1,090,289 aged-matched, non-adopted peers. The studies included both questionnaire-based studies that used parental or self-reporting of problems and register-based studies where mental health problems were gleaned from health record data. 

The analysis revealed that international adoptees had higher scores on total mental health problems than non-adopted peers, with register-based studies showing a greater standardized mean difference (0.70) than questionnaire-based studies (0.16). There were greater differences between adoptees and non-adoptees when categorical measurements of mental illness, indicating more serious problems, were used. Among the questionnaire-based studies, mental health differences between international adoptees and their peers were larger when using parent reports compared with self-reports. 

Neither age at adoption nor sex appeared to influence the likelihood of mental health problems in the adopted youth.

“It is important to stress that children who are adopted internationally benefit from the change adoption provides and show positive development after adoption,” the authors concluded. “However, although most internationally adopted adolescents are well adjusted, the increased risk of mental health problems must be acknowledged to facilitate the prevention of such problems in this group. … Adoption-related competence can be gained by contacting local adoption agencies for information or by internet-based training, which is provided by, for instance, the Center for Adoption Support and Education in the United States.”

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Friday, March 3, 2017

Patients With Predominant Negative Symptoms Show Some Improvements on Cariprazine

While most current antipsychotics are effective at reducing the positive symptoms of schizophrenia, treating negative symptoms such as anhedonia and cognitive challenges associated with the disorder has proven much more difficult. A study published in the Lancet is the latest of several trials that seem to suggest cariprazine may be able to help patients with predominant negative symptoms of schizophrenia.

Cariprazine, which was approved by the Food and Drug Administration in 2015 to treat adults with schizophrenia and manic/mixed episodes of bipolar disorder, generated some excitement early on after trials suggested the medication led to improvements in positive and negative symptoms. But these trials were unable to determine whether the improvements in negative symptoms were directly from the medication or secondary to improvements in positive symptoms or comorbid depression (Psychiatric News, October 16, 2015).

As described in an article appearing today in Psychiatric News PsychoPharm, the authors of the current study sought to tease apart these two possibilities by assessing only patients with predominantly negative symptoms. Patients with long-term stable schizophrenia and predominant negative symptoms for more than six months were randomly assigned to once-daily cariprazine (3 to 6 mg/day) or risperidone (3 to 6 mg/day) for 26 weeks.

After 14 weeks, patients taking cariprazine began to show greater improvements in both negative symptoms (measured with the Positive and Negative Syndrome Scale, PANSS) and psychosocial functioning (measured using the Personal and Social Performance Scale, PSP) compared with patients on risperidone. By week 26, the cariprazine group had experienced an average decline of 8.90 points in the PANSS negative scores compared with a decline of 7.44 points in the risperidone group. For PSP, cariprazine patients saw a 14.30-point improvement compared with 9.66-point improvement for risperidone.

“The effect sizes were modest, but the study identified consistent advantages for cariprazine for a variety of measures,” John Kane, M.D., the chair of psychiatry at the Zucker Hillside Hospital in Glen Oaks, N.Y., told Psychiatric News. Kane has carried out clinical trials with cariprazine previously, but he was not involved with this trial. Given the lack of options for patients with elevated negative symptoms, “this was exactly the kind of study needed to advance the field of schizophrenia therapy,” he added.

For more on the trial and what the findings might mean for psychiatry, see “Study Suggests Cariprazine May Have Direct Effects on Negative Symptoms.”

(Image: iStock/Portra)

Thursday, March 2, 2017

Psychotherapies Effective for BPD, But Effects are Small, Study Says

Some psychotherapies are effective for alleviating some symptoms of borderline personality disorder (BPD) and related problems, but effects are small, and studies are plagued by methodological problems, according to a meta-analysis published yesterday in JAMA Psychiatry.

The study found that dialectical behavior therapy (DBT) and psychodynamic approaches to treating people with BPD demonstrated efficacy for borderline-relevant symptoms such as self-harm, suicide, health service use, and general psychopathology.

Researchers from several international institutions searched PubMed, PsycINFO, EMBASE, and the Cochrane Central Register of Controlled Trials using the terms “borderline personality” and "randomized trial.” Thirty-three trials with 2,256 participants were included.

Standardized mean differences in efficacy were calculated using all outcomes reported in the trials for borderline symptoms including self-harm, suicide, health service use, and general psychopathology.

The results showed significant but small, posttest between-group effect sizes in all outcome categories. For borderline-relevant outcomes and psychopathology, effects were small to medium. There were no differences between types of psychotherapies; most trials focused on DBT followed by psychodynamic approaches, and both types generated significant but still small effects compared with comparison interventions.

Statistical analysis suggested that the results may be inflated by risk of bias (greater attention paid to patients in experimental arms) and publication bias (the likelihood that trials would be published when results were favorable to the experimental arm).

The researchers noted that further research is needed and that prospective registration in clinical trial registries is necessary to address methodological problems in research on psychotherapy for BPD. 

Peter Fonagy, Ph.D., and colleagues concurred in an accompanying editorial. “While these findings provide further support for cautious optimism in relation to the role of specialized psychotherapy (and psychotherapy more generally) in treating BPD, the meta-analysis by Cristea, et al., also highlights important limitations and concerns that the field needs to urgently address.”

For related information, see the Psychiatric News article "Recovered BPD Patients More Likely to Marry, Have Children."

(Image: sturti/

Wednesday, March 1, 2017

APA Task Force Addresses Off-Label Use of Ketamine

Despite escalating demand for clinical access to ketamine treatment and an increasing number of clinicians willing to provide it, big questions remain about the durability and safety of the anesthetic for the treatment of mood disorders. In a report published today in JAMA Psychiatry, the APA Council of Research Task Force on Novel Biomarkers and Treatments presents an overview on ketamine use and highlights critical issues for clinicians to consider about off-label use to help ensure patient safety.

The authors noted that the report is intended to complement a meta-analysis conducted by the Task Force in 2015. The report is broken down into the following sections:

  • Patient Selection
  • Clinical Experience and Training
  • Treatment Setting
  • Medication Delivery
  • Follow-up and Assessments
  • Efficacy of Longer-Term Repeated Administration
  • Safety Measures and Continuation of Treatment
  • Future Directions

“The rapid onset of robust, transient antidepressant effects associated with ketamine infusions has generated much excitement and hope for patients with refractory mood disorders and the clinicians who treat them. However, it is necessary to recognize the major gaps that remain in our knowledge about the longer-term efficacy and safety of ketamine infusions,” the authors wrote. “Although economic factors make it unlikely that large-scale, pivotal phase 3 clinical trials of racemic ketamine will ever be completed, there are several studies with federal and private foundation funding aiming to address some of these issues.

“It is imperative that clinicians and patients continue to consider enrollment in these studies when contemplating ketamine treatment of a mood disorder. It is only through these standardized clinical trials that we will be able to collect the data necessary to answer some of the crucial questions pertaining to the efficacy and safety of the drug.”

The authors also pointed to the value that a registry of patients treated with ketamine could offer for the field.

“Ketamine provides new excitement for psychiatry and offers the hope of much-needed novel and perhaps more effective treatments,” Charles Zorumski M.D., and Charles Conway, M.D., of Washington University School of Medicine, wrote in an accompanying editorial. “The consensus statement by Sanacora and colleagues, however, provides a sobering cautionary guide, especially as we move toward attempting to sustain the gains achieved by acute doses of ketamine. This consensus statement will not be the final word on this topic, and similar considerations will be needed for other novel treatments.”

For related information, see the Psychiatric News articles “Ketamine Clinics Attract Patients Despite Unknowns” and “APA Task Force to Address ‘What’s Next?’ for Ketamine.”

(Image: iStock/teetuey)


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