Monday, October 16, 2017

Lurasidone Benefits Youth With Bipolar Depression Without Major Side Effects

Lurasidone appears to be well tolerated and effective at reducing depressive symptoms in children and adolescents with bipolar I depression, reports a study published Friday in Journal of the American Academy of Child and Adolescent Psychiatry

After six weeks, youth with bipolar depression assigned to daily lurasidone showed significant improvements in their Children’s Depression Rating Scale–Revised (CDRS-R) scores compared with those assigned to placebo. Youth taking lurasidone also demonstrated improvements in anxiety, quality of life, and global functioning.

“In addition to significantly higher responder rates in patients treated with lurasidone versus placebo, the clinical relevance of improvement in the lurasidone group is underscored by the observed change in mean [global functioning] score from <50 at baseline (‘moderate-to-severe impairment in functioning’) to >60 at study endpoint (‘generally functioning pretty well’),” wrote Melissa DelBello, M.D., of the University of Cincinnati College of Medicine and colleagues. “The consistency of improvement across primary, key secondary, and all other secondary efficacy measures further substantiates the overall effectiveness of lurasidone in this pediatric population with bipolar depression.”

This study included 347 pediatric patients aged 10 to 17 with bipolar I disorder and CDRS-R scores of at least 45. The participants were randomly assigned to either lurasidone (20-80 mg daily) or placebo. At the study endpoint, CDRS-R total scores dropped 21 points in the lurasidone group compared with 15.3 points in the placebo group. Overall response rates (≥50% reduction from baseline to week 6 in CDRS-R total score) were 59.5% and 36.5% for the lurasidone and placebo groups, respectively.

DelBello and colleagues noted the improvements seen in the current study were comparable to those seen in a clinical trial of olanzapine/fluoxetine combination (OFC) therapy, but lurasidone had a better tolerability profile. 

The dropout rates among patients due to adverse events were low and similar for both groups in the lurasidone study (1.7% compared with 14.1% in the aforementioned OFC study). The two most common adverse events among patients taking lurasidone were nausea and somnolence. There were no significant differences in weight gain between lurasidone and placebo groups.

For related information, see the FOCUS article “Management of Bipolar Disorder in Children and Adolescents,” by DelBello and colleagues.

(Image: iStock/gradyreese)

Friday, October 13, 2017

APA Speaks Out Against the Administration’s Latest Moves to Unravel ACA

APA and five other medical specialty organizations are strongly opposing actions taken yesterday by the Trump administration to undermine the Affordable Care Act.

They say that a White House executive action allowing individuals and small employers to purchase certain types of low-cost health insurance plans and the halting of subsidies to health plans that help pay for coverage of low-income families will destabilize health insurance markets and prevent access to care by millions of Americans.

The five other organizations are the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American Osteopathic Association. Together, they represent more than 560,000 physicians and medical students nationwide.

President Trump’s decision to end subsidies supporting coverage of low-income families is especially egregious, APA and the five other groups said, raising costs for the most vulnerable individuals and families and for the federal government. 

“This decision is not consistent with the administration’s pledge to provide individuals and families with more options to secure affordable health care coverage,” the group said in a joint statement issued today. “Elimination of cost-sharing reduction payments makes that goal harder, if not impossible, to achieve.

“Our organizations call on the United State Senate and House of Representatives to take immediate action to restore these payments. A failure to address this matter will result in dramatic, if not catastrophic, increases in premiums across the country—resulting in millions of people either losing their health care coverage due to either insurer departures from the market or their inability to afford coverage.”

Further, APA and the other five groups said that the executive order that instructs federal agencies to promulgate regulations allowing individuals and small employers to purchase low-cost, bare-bones health insurance plans will allow for discrimination against certain populations and provides no economic security for those holding such a policy. “These plans would be exempt from consumer protections and insurance regulations provided under current law. By waiving such protections, insurers would be allowed to establish their coverage determinations and premiums based on health status, age, and gender. Furthermore, these plans would not be required to provide the core comprehensive benefits such as vaccines, life-saving medical screenings, prevention and treatment of opioid and other substance use disorders necessary to provide the comprehensive care working families need.”

APA and the other groups concluded, “We remain committed to working with the administration and the United States Congress to improve our nation’s health care system. However, we cannot and will not support efforts to deliberately undermine and destabilize our health care system.”

Look for further coverage in Psychiatric News.

(Image: Shutterstock/Mikhail Kolesnikov)

Thursday, October 12, 2017

Insomnia Symptoms, Sleep Medications Increase Risk of Falls in Seniors

The more insomnia symptoms an older adult reports, the greater their risk of future falls, according to a study published in the journal Sleep. This risk appears to be even greater in older adults who took physician-recommended sleep medications.

“Multiple insomnia complaints are common among older adults, and our findings suggest that investigating a single insomnia symptom may underestimate the impact of multiple co-existing insomnia symptoms on fall risk,” wrote Orfeu Buxton, Ph.D., and colleagues at the Pennsylvania State University Center for Healthy Aging.

Buxton and colleagues analyzed data from the 2006 through 2014 versions of the Health and Retirement Study (HRS), an ongoing national study that interviews older adults every two years on a variety of health and lifestyle topics. The HRS includes sleep-related questions such as whether the participants have trouble “falling asleep,” “waking up during the night,” “waking up too early and not being able to fall asleep again,” and “not feeling rested during the day.” The researchers compiled answers from participants aged 65 and older to create a composite insomnia score of 0-4 for each respondent. As part of the HRS interview, participants were also asked whether they had fallen since the previous assessment (last two years).

They found that a higher insomnia score correlated with a future risk of falling. Specifically, older adults were 5% more likely to report a fall for each insomnia symptom they had. In addition, adults who used physician-recommended sleep medications were approximately 34% more likely to report a fall at the survey two years later compared with adults who did not use sleep medications. Interestingly, nonphysician-recommended sleep medications showed no association with falls at follow up.

“It is … important for clinicians to screen older adults for the presence of insomnia and make a referral to a specialist in sleep disorders if needed,” Buxton and colleagues wrote. “CBT-I [cognitive-behavioral therapy for insomnia] has been found to be effective in treating insomnia among older adults and in sustaining the effects longer compared with sleep medications or other treatments … with potentially fewer side effects for falls.”

For related information, see the Psychiatric News article “Online CBT for Insomnia Offers Long-Term Benefit.”

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Wednesday, October 11, 2017

Spending More Time on Exposure Tasks During CBT May Improve Outcomes in Anxious Youth

Encouraging youth with anxiety disorders to gradually confront anxiety-provoking situations is recognized as a key component of cognitive-behavioral therapy (CBT), but few studies have examined specific exposure characteristics that predict treatment outcomes. A study published Monday in the Journal of the American Academy of Child and Adolescent Psychiatry suggests the number of CBT sessions in which exposure tasks are practiced may predict treatment outcomes.

[T]he findings support the importance of prioritizing exposure tasks within CBT sessions, revealing a positive link between the number of sessions in which exposure is practiced and favorable outcome,” Tara S. Peris, Ph.D., of the UCLA Semel Institute for Neuroscience and Human Behavior and colleagues wrote. “This link appears to be especially important for younger children, whose developmental level may limit the benefit of cognitive restructuring, another critical element of treatment.”

Peris and colleagues analyzed a subset of data from youth aged 7 to 17 who participated in the Child/adolescent Anxiety Multimodal treatment Study (CAMS). The study participants, all whom had been diagnosed with separation anxiety disorder, generalized anxiety disorder, or social phobia, were randomly assigned to CBT (n = 139) or a combination of CBT and sertraline (n = 140) for 12 weeks. Youth in both groups received 14, 60-minute sessions; during CBT sessions 1-6, youth learned about skills for managing anxiety, and during CBT sessions 7-14, youth were exposed to anxiety-provoking situations. Youth in the combination therapy group also received sertraline (starting with 25 mg/day and adjusting up to 200 mg/day by week 8).

The researchers used regression analyses to examine the impact of five therapist-reported exposure characteristics on acute treatment outcomes: the percentage of treatment sessions that included exposure exercises; percentage of exposure sessions that included challenging (versus easy or medium) exposure tasks as rated by therapists based on each youth’s Subjective Units of Distress Scale ratings/symptom hierarchy; cumulative dose of exposure; average clinician rating of the youth’s skill mastery during sessions focused on exposure; and average clinician rating of the youth’s treatment compliance during sessions that focused on exposure.

These analyses revealed “a dose-response relationship between therapist-reported quantity of exposure and independent evaluations of treatment outcome, with more time devoted to exposure linked to better outcomes. Similarly, greater time spent on more difficult (rather than mild or moderate) exposure tasks predicted better outcomes, as did therapist ratings of child compliance and mastery,” the authors reported. The findings highlight the importance of collaborating with youth to understand the reasoning behind exposure practice and repeating/revisiting specific tasks to ensure a sense of mastery. 

For related information, see the Psychiatric News article “Child Psychiatrists Look at Specialty From Both Macro, Micro Perspectives.”

(Image: Monkey Business Images/Shutterstock)

Tuesday, October 10, 2017

Computer-Assisted CBT for Depression Found Equivalent to Standard CBT

Patients with major depressive disorder who used a computer-assisted form of cognitive-behavioral therapy (CBT) in conjunction with visits with a therapist experienced similar remission rates as those who received traditional CBT for 16 weeks, according to a report in AJP in Advance.

The computer-assisted CBT (CCBT) entailed fewer visits with a therapist than standard CBT, theoretically increasing efficiency and lowering costs. “With increasing utilization of computers in society, improvements in broadband speed and access, and continued work on enhancing the quality of online CCBT programs, computer-assisted methods that reduce costs and improve the efficiency of psychotherapy offer a valuable means to make treatment available to larger numbers of people with depression,” wrote Michael Thase, M.D., of the Perelman School of Medicine at the University of Pennsylvania and colleagues.

The researchers randomized a total of 154 medication-free patients with major depressive disorder to either 16 weeks of standard CBT (up to 20 sessions of 50 minutes each over 16 weeks) or 16 weeks of CCBT using the “Good Days Ahead” (GDA) program, consisting of the nine Internet-delivered modules of GDA and 12 sessions with a therapist. The modules used a blend of video illustrations, psychoeducation from a psychiatrist-narrator, feedback to users, mood graphs to measure progress, interactive skill-building exercises that help users apply CBT methods in daily life, and quizzes to assess comprehension and promote learning. A clinician dashboard allowed therapists to assess progress, view learning exercises, and coordinate all aspects of treatment.

The CBT group received 8.3 more hours of therapist contact than the CCBT group, which corresponds to 10 fewer 50-minute visits across 16 weeks. Both groups experienced large improvements and similar rates of symptom reduction across the 16 weeks of treatment. Among those who completed treatment, remission rates (defined as a score ≤7 on the Hamilton Depression Rating Scale) at week 16 were 46.9% (30/64) for the CCBT group and 48.4% (30/62) for the CBT group. These improvements were maintained in both groups at follow-up visits three and six months later. Among the 55 participants who had remitted at week 16 and completed the follow-up, only six relapsed (11%), two in the CBT group (7%) and four in the CCBT group (16%).

“Because CCBT reduces the ‘dose’ of therapist time, it is possible that this form of treatment would be less effective than standard CBT for patients with higher symptom severity or more complex, long-standing depressions,” Thase and colleagues wrote. “We also did not enroll patients who wanted to receive concomitant antidepressant therapy, which may have skewed sampling toward a subset of patients who were more highly motivated for psychotherapy. It would be worthwhile in future research to study a wider range of depressed patients, including those who prefer combined treatment with antidepressants and those have not obtained an adequate response to pharmacotherapy.”

For related information, see the Psychiatric News article “Online CBT-I Program May Reduce Depression, Anxiety Symptoms” and the Psychiatric Services article “Technology in Mental Health: Creating New Knowledge and Inventing the Future of Services.”

(Image: iStock/Georgijevic)

Friday, October 6, 2017

Early Intervention Found to Promote Greater Adherence to Antidepressants

Patients who participated in a brief psychosocial intervention program were more likely to adhere to their prescribed medication for depression than patients who received treatment as usual, according to a study published in JAMA Psychiatry.

“The program helps patients address barriers [such as stigma, misconceptions, and fears], identify treatment benefits, and feel empowered to manage their medication regimen and communicate with the physician effectively,” wrote Jo Anne Sirey, Ph.D., a professor of clinical psychology in psychiatry at Weill Cornell Medical College, and colleagues. 

A total of 231 adults aged 55 and older who had been recently prescribed an antidepressant by their primary care physician for depression were randomly assigned to receive either the Treatment Initiation and Participation (TIP) intervention and antidepressant monitoring by their primary care physician or only treatment monitoring by their primary care physician.

Patients in the TIP group met with social workers for three, 30-minute meetings over the first six weeks of antidepressant treatment. The intervention included five steps: 1) review symptoms and antidepressant regimen and conduct a barriers assessment; 2) define a personal goal that could be achieved with adherence; 3) provide education about depression and antidepressant therapy; 4) collaborate to address barriers to treatment participation; and 5) create an adherence strategy and empower the older adult to talk directly with the primary care physician about treatment. 

At the start of the study and at weeks 6, 12, and 24, the researchers used the Brief Medication Questionnaire and the 24-item Hamilton Depression Rating Scale (HAM-D) to assess antidepressant adherence and depression symptoms. Adequate early adherence was defined as taking 80% or more of the prescribed doses at 6 and 12 weeks.

Sirey and colleagues found that throughout the study period, rates of adherence were higher among participants in the TIP group; these patients were five times more likely to adhere to their antidepressant at week 6, and nearly three times more likely to be adherent at both 6 and 12 weeks. Although TIP was not associated with overall improvement of depression, patients in the TIP group showed a significant earlier reduction in depressive symptoms at six weeks, the authors noted.

“Given the high rates of depression, nonadherence, and use of primary care as a mental health service, wide-scale implementation of a targeting adherence intervention such as TIP could have a meaningful impact on public health,” Sirey and colleagues concluded. “Improved adherence can promote improvement in depression.” 

For related information, see the Psychiatric News article “Low-Cost Reminders Fail to Improve Medication Adherence.”

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Thursday, October 5, 2017

Even Low Levels of Exercise May Prevent Later Depression, Study Finds

Regular leisure-time exercise may reduce the risk of future depression but not anxiety, according to a large population study published in AJP in Advance

“The majority of this protective effect occurred at low levels of exercise and was observed regardless of [exercise] intensity,” wrote Samuel B. Harvey, Ph.D., an associate professor at the University of New South Wales, and colleagues. “Assuming there is no residual confounding in our final model and the observed relationship is causal, our results suggest that if all participants had exercised for at least one hour each week, 12% of the cases of depression at follow-up could have been prevented,” the authors wrote. 

The study drew upon a prospective, Norwegian cohort (33,908 people), having no symptoms of common mental disorder or limiting physical health, to address three questions:  1) Does exercise provide protection against new-onset depression and anxiety? 2) If so, what intensity and total amount of exercise is required to gain protection? 3) What causal mechanisms underlie any association between exercise and later depression and anxiety?

In phase 1 of the Health Study of Nord-Trondelag County (HUNT 1), all residents of a rural county in Norway aged 20 years or older were invited to complete questionnaires about their lifestyles and medical histories and undergo a physical exam. As part of the baseline HUNT 1 assessment, participants were asked about depression and anxiety symptoms as well as how often they exercised and the intensity of this exercise. 

Data from HUNT 1 were used to select a “healthy” cohort without any evidence of current physical illness or depressive or anxiety disorders at baseline that was followed up nine to 13 years later in HUNT 2. Of the 22,564 individuals successfully followed in HUNT 2, 1,578 (7%) developed case-level symptoms of depression and 1,972 (8.7%) developed case-level symptoms of anxiety (as measured by Hospital Anxiety and Depression Scale). The prevalence of case-level anxiety was similar regardless of the participants’ levels of baseline exercise; therefore, no association between baseline exercise levels and later case-level anxiety could be made.

Participants who reported undertaking no exercise at baseline had 44% increased odds of developing case-level depression compared with those who exercised one to two hours per week. 

“Those who engaged in less exercise at baseline tended to have higher resting pulse, lower levels of perceived social support, and more sub-threshold symptoms of depression and anxiety, and they were more likely to develop new-onset physical illnesses over the course of the study,” noted the researchers. “Importantly, the majority of the protective effects of exercise against depression are realized within the first hour of exercise undertaken each week, which provides some clues regarding causation and has major implications for possible future public mental health campaigns.”

For related information, see the Psychiatric News article “Productivity, Exercise May Predict Antidepressant Response.”

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