Wednesday, December 20, 2017

APA Criticizes Tax Bill as Unnecessary Attack on Nation’s Health Care

Congressional Republicans along with President Donald J. Trump celebrated the final passage today of a sweeping tax reform bill that slashes corporate taxes while also gutting the central tenet of the Affordable Care Act. Expressing disappointment, APA said the bill causes “unnecessary damage” to the nation’s health care system.

The core of the Tax Cuts and Jobs Act is a huge cut to the corporate tax rate, dropping it from 35% to 21%. The measure also cuts individual tax rates for all income tax levels, with most of the benefits going to those earning more than $300,000, according to the nonpartisan Tax Policy Center.

The final bill passed the House 224-201, with no Democrats backing it and 12 Republicans dissenting. The president is expected to sign the bill into law as soon as it is enrolled.

Repeal of the individual mandate in the Affordable Care Act “sacrifices the health care of 13 million Americans who will lose their insurance by 2027,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a press statement. The change is projected to save the government $300 billion over a decade.

“By significantly raising the federal deficit, this bill sets the stage for future cuts to Medicare and other critical safety net programs,” Levin continued. “What is being sold as a tax cut bill is also an attack on our health care system. There is no reason for these two issues to be decided by the same vote.”

According to a coalition of six physician organizations of which APA is a member, repealing the individual mandate will increase premiums and destabilize the individual and small group markets. People with mental illness were more likely to be insured after the implementation of the ACA (5% versus 13%), according to a recent APA survey.

“We need Congress to pass legislation that will stabilize the ACA markets and shore up our health care system,” Levin said. “We stand ready to work with Congress on a thoughtful, bipartisan approach to health care reform.”

The measure leaves untouched health savings accounts. These are savings accounts linked to high-deductible health insurance plans and exempt from tax liability.

This is the last issue of the PN Alert for 2017; Alerts will resume publication on Tuesday, January 2. Happy Holidays!

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Tuesday, December 19, 2017

Cannabidiol May Be Effective Adjunct to Antipsychotic Treatment for Schizophrenia Patients

Patients with schizophrenia who are prescribed cannabidiol (CBD) in addition to antipsychotics may experience lower levels of positive psychotic symptoms compared with those taking antipsychotics alone, according to a report in AJP in Advance. The study also found that use of CBD as an adjunctive therapy for this population may also improve cognitive performance and overall functioning.

“Because CBD acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” wrote Philip McGuire, M.D., of the Institute of Psychiatry, Psychology, and Neuroscience at King's College London and colleagues. “However, its potential clinical utility will require further investigation in larger-scale trials.”

McGuire and colleagues recruited patients with schizophrenia who had previously demonstrated at least a partial response to antipsychotic medication and had been receiving a stable dose of antipsychotic medication for at least four weeks. A total of 88 patients were randomly assigned to take cannabidiol (1000 mg/day; n=43) or placebo (n=45) in addition to their existing antipsychotic medication.

The researchers evaluated patients’ symptoms, general functioning, and cognitive performance, among other measures at baseline and on days 8, 22, and 43. Clinicians also recorded impressions of patient severity, improvement, and general functioning.

After six weeks, patients in the CBD group experienced a greater reduction in positive psychotic symptoms (measured using the Positive and Negative Syndrome Scale) from baseline compared with the placebo group. At the end of treatment, a significantly higher proportion of patients in the CBD group were rated by their clinician as “improved” on the Clinical Global Impression scale compared with those in the placebo group (78.6% and 54.6%, respectively).

Cognitive performance, as measured by the Brief Cognitive Assessment Scale (BACS), was also greater among patients receiving cannabidiol, although it fell short of statistical significance. However, analysis of the individual BACS domains showed that there was a significantly greater improvement in motor speed in the cannabidiol group compared with the placebo group.

CBD was well tolerated, and rates of adverse events were similar between the CBD and placebo groups.

For related information, see the Psychiatric News article “Cannabidiol May Benefit Patients With Early Psychosis, Cannabis Misuse.”

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Monday, December 18, 2017

Rise in Antidepressant Prescriptions for Youth Raises Questions About Why

The number of prescriptions of antidepressants for children and adolescents fell after the Food and Drug Administration in 2004 directed pharmaceutical companies to issue a black-box warning about the potential link between antidepressant use and the risk of increased suicidal ideation among youth. A study published in Psychiatric Services now shows that following that initial decline, the rate of antidepressant prescribing to children returned to pre-2004 levels within a few years. 

Nilay Kafali, Ph.D., of RTI International and colleagues found that 2.26% of children aged 5 to 17 were prescribed antidepressants in 2009, similar to the 2003 level of 2.29%. Between 2004 and 2008, that rate had dropped to below 2%.

The authors calculated these rates using data from the Medical Expenditure Panel Survey (a set of nationally representative surveys of individuals, medical providers, and employers that detail the usage and costs of health care services and health insurance coverage). They included available data on children aged 5 to 17 between 2000 and 2011. To estimate how the impact of the black-box warning on antidepressant use among children changed over time, the authors divided the entire sample period into four periods: early prewarning (2000–2001), prewarning (2002–2003), early postwarning (2004–2007), and late postwarning (2008–2011). 

They found that there was a 0.5% statistically significant decline in antidepressant use during the early postwarning years compared with prewarning years, with a particularly strong decrease among children rated as having non-severe psychological impairment (which the authors defined as a Columbia impairment Scale score of <16). By 2009, though, the rates had returned to pre-2004 levels.

“These findings suggest that providers and families of youths may have reacted to the black-box warning in an appropriate manner, weighing the warning with the risks and benefits of the treatment,” Kafali and colleagues wrote. “A return to the rates of antidepressant use before the black-box warning raises concern that this thoughtful accounting of the risks and benefits may have dissipated over time.”

“It is possible that over time physicians have become somewhat inured to the safety warnings,” said Mark Olfson, M.D., M.P.H., a professor of psychiatry and epidemiology at Columbia University Medical Center, who was not involved with this study. “However, it is also possible that increasing prevalence of depression or anxiety among young people during the great recession played a role,” he added.

Olfson, who was not involved with this study, noted that other community surveys including the Youth Risk Behavior Survey, the National Survey on Drug Use and Health, and the Monitoring the Future surveys have revealed a recent increase in depressed mood and major depressive episodes among children and adolescents. 

For related information, see the Psychiatric News article “U.S. Experiences Uptick in Rates of Suicide.”

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Friday, December 15, 2017

Study Examines Relationship Between History of SSRI Use By Dads, ADHD in Offspring

A study published this week in Pediatrics suggests that children whose fathers took selective serotonin reuptake inhibitors (SSRIs) before the children were conceived may be more likely to develop attention-deficit/hyperactivity disorder (ADHD) than those whose fathers did not take SSRIs. However, the study authors cautioned that this increased risk may be due in part to the fathers’ underlying mental health disorder related to their SSRI use.

To examine the risk of ADHD in children whose fathers took SSRIs within three months of conception, researchers at the University in Shanghai and Aarhus University Hospital in Denmark conducted a nationwide cohort study of children born in Denmark between 1996 and 2008. The authors focused on the three-month cut off because it takes sperm roughly 70 to 90 days to fully mature (several studies have suggested that SSRIs may compromise sperm, which is associated with increased risk of disease in offspring). Children were followed from age 3 until the first diagnosis of ADHD, death, emigration, or December 31, 2013, whichever came first.

Among the 781,470 single births included in the study, 12,520 children were later diagnosed with ADHD. A total of 7,216 children were born to fathers who had used SSRIs during the last three months before conception.

Compared with children whose fathers did not take SSRIs during the period examined, the exposed children had a 26% increased risk of ADHD after adjustment for potential confounders, according to the authors. When the researchers compared the ADHD rates in offspring of men who took SSRIs three to 12 months before conception with those who took SSRIs within the three-month period before conception, they found that both groups displayed roughly equivalent risks of having children with ADHD.

Further, when the authors analyzed data from families with more than one child and with at least one child with paternal SSRI preconception exposure, they found the risk of ADHD in exposed children decreased when compared with their unexposed siblings (adjusted hazard ratio=0.68).

“On the basis of these results, the authors concluded that although there is some increased risk among SSRI users, the underlying paternal mental health disease may itself be a risk factor for ADHD in offspring,” wrote Craig F. Garfield, M.D., of Northwestern University Feinberg School of Medicine in a related editorial.

“From a clinical perspective, this study reinforces the importance of identifying mental health disorders among men transitioning to fatherhood and among current fathers,” Garfield said. “[P]roviding treatment of fathers’ underlying mental health disorders may improve fathers’ and families’ functioning, ultimately improving their children’s outcomes.”

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Thursday, December 14, 2017

Federal Agencies Must Provide Better Care for People With SMI, Says SAMHSA Report

Too many individuals with serious mental illness (SMI) are not getting the treatment and support they need because of fragmented federal systems that are providing inadequate services, according to the first report by a federal committee tasked with improving care for this population. The report was delivered to Congress and issued to the public today.

The Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) was created as part of the 21st Century Cures Act. It aims to enhance coordination across federal agencies that impact the care of adults and youth with SMI. Serious mental illness is defined as a mental illness that seriously impacts the ability to work, live, or form relationships with others.

The report noted that there were 10 million American adults living with a serious mental illness in 2016, and 35% received no treatment. More than 7 million youth experienced a serious emotional disturbance (SED). Both populations face a greater risk of suicide and a life expectancy 10 years shorter than that of the general population. Because of inadequate mental health resources, 2 million people with SMI are incarcerated each year. 

The committee brings together representatives from eight federal government departments that support programs for individuals with SMI or SED, including the departments of Health and Human Services (HHS); Justice; Labor; and Housing and Urban Development, along with nonfederal members including researchers, advocates, and health care professionals. 

“Too often, people with SMI or SED lack access to evidence-based treatments, so they experience high rates of homelessness, joblessness, disability, involvement with the criminal justice system, premature death, and other negative outcomes,” said Elinore F. McCance-Katz, M.D., Ph.D., assistant secretary for mental health and substance use at HHS, head of the Substance Abuse and Mental Health Services Administration, and chair of ISMICC. “Our health care system can do better, and the federal government can marshal its resources to help make that happen.”

The committee offered five basic recommendations on how the federal government could improve the care it provides and the outcomes for this population: strengthen federal coordination between departments to allow for better care, improve access and engagement to make it easier to get high-quality care, close the gap between effective treatments that are known to work and what is actually offered, boost diversion from and treatment for people with SMI in the criminal and juvenile justice systems, and develop finance strategies to make care more available and affordable. 

APA welcomed the report and is looking forward to seeing the responses of federal agencies. “Our members are ready to work with the administration and Congress to implement the recommendations made today,” APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a press statement. “Our patients deserve the best care possible, and today’s report is a step in the right direction.”

ISMICC is required to issue a second report to Congress in four years. 

(Image: David Hathcox)

Wednesday, December 13, 2017

Folate, Vitamin D Found Lower in People Who Have Experienced First-Episode Psychosis

Patients who have experienced first-episode psychosis (FEP) appear to have significantly lower levels of folate and vitamin D in their blood compared with individuals with no psychiatric diagnosis, according to a report in Schizophrenia Bulletin.

Understanding nutritional deficits that exist from illness onset could lead to nutrient-based interventions to improve diet and possibly reduce symptoms in people with FEP, the authors wrote.

Previous studies have suggested that individuals with schizophrenia have low levels of B vitamins (B12 and folate), antioxidant vitamins (C and E), and vitamin D. However, which nutritional deficiencies are present at the first episode of psychosis was previously unknown.

Joseph Firth, Ph.D., of the University of Western Sydney and colleagues analyzed data from 28 studies that compared the blood levels of vitamins and minerals of people with and without FEP. These studies, which included 2,612 individuals (1,221 people with FEP and 1,391 controls), assessed differences in blood levels of six vitamins (A, B12, C, D, E, and folate) and 10 minerals (calcium, chromium, copper, iron, magnesium, manganese, potassium, selenium, sodium, and zinc).

The meta-analysis revealed significant reductions in folate and vitamin D among people with FEP compared with nonpsychiatric controls, with the strongest evidence found for vitamin D deficits. Lower folate and vitamin D levels were also found to be associated with more severe symptomology in individuals with FEP.

Although only examined in two studies, vitamin C was also significantly reduced in patients with FEP. There were no significant differences between people with and without FEP with regard to the levels of other vitamins and minerals—a finding that could be due to the fact that some of the studies of other nutrients included only a small number of people with FEP, the authors said.

“Further longitudinal and interventional research in individuals identified at ‘ultra-high risk’ for psychosis would provide valuable insights into both the predictive value of nutritional deficiencies in the onset of psychosis, along with potentially determining if nutritional supplementation can confer any benefit for reducing psychosis risk,” Firth and colleagues conclude.

For related news, see the Psychiatric News articles “D.C. Psychiatric Society Hosts Panel on Nutrition and Psychiatry” and Long Career Studying Choline Leads to Public Health Payoff.

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Tuesday, December 12, 2017

Incorporating Social Therapy Into Early Psychosis Intervention Improves Social Engagement

Despite considerable evidence showing the benefit of early intervention services on social recovery in people with first-episode psychosis, many will continue to experience severe and persistent social impairments. A study published yesterday in Lancet Psychiatry suggests that combining early psychosis intervention with social recovery therapy may help to further improve patient outcomes, particularly in individuals who lack the motivation or ability to engage in existing psychosocial interventions.

The social recovery program examined in the study was a three-step approach aimed at (1) establishing a working therapeutic relationship and assessing patient goals, (2) working together to identify ways to initiate meaningful new activities, and (3) engaging in new activities and fostering a sense of mastery and agency in the patient.

David Fowler, M.Sc., of the University of Sussex and colleagues recruited patients aged 16 to 35 with non-affective psychosis who had participated in early intervention services for 12 to 30 months and had low levels of structured activity (defined as ≤30 h/week on the Time Use Survey). Structured activities assessed by the Time Use Survey include work, education, voluntary work, leisure, sports, housework or chores, and child care.

The researchers assigned 155 patients to either early intervention services alone or in combination with social recovery therapy for nine months. 

After nine months, participants who received both psychosis intervention and social therapy engaged in eight more hours of structured activities each week compared with those receiving only early intervention.

“The effect size after treatment is clearly of clinical benefit, especially given the extreme social withdrawal present at baseline,” wrote Fowler and colleagues. They noted that the participants only engaged in around 12 hours of activities per week at baseline. “The size of the effect is twice that identified by consensus groups of users and clinicians as the minimum clinically important difference and represents an amount of activity equivalent to a working day.”

A secondary analysis to see if these improvements persisted six months after the treatments ended (15 months post-baseline) was inconclusive. The authors noted that this may have been due to a high amount of patient dropout after the interventions ended.

For related information, see the Psychiatric News article “Psychosocial Treatments Found Effective for Early Psychosis” and the Psychiatric Services article “Providing Recovery-Oriented Early Intervention Services to Youths Experiencing First-Episode Psychosis.”

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Monday, December 11, 2017

Pregnant Women With Dissociative Subtype of PTSD Have Higher Levels of Cortisol, Study Finds

Pregnant women with a severe subtype of posttraumatic stress disorder (PTSD) appear to have higher levels of the stress hormone cortisol than other pregnant women with a history of trauma, reports a study in the Journal of Obstetric, Gynecological, and Neonatal Nursing. Such high levels of cortisol may contribute to adverse health conditions in the next generation, according to the study authors.

“Exposure to early relational trauma that predisposes a person to dissociation and PTSD may affect that individual’s short- and long-term cortisol patterns,” wrote Julia S. Seng, Ph.D., of the University of Michigan and colleagues. Previous studies suggest that elevated cortisol levels are a risk factor for preterm birth, affecting the onset of labor and inflammatory processes.

A diagnosis of PTSD may include a dissociative subtype (PTSD-D) characterized by altered perception of oneself and the world. PTSD-D is associated with a greater number of lifetime trauma exposures, including a history of childhood maltreatment.

The study by Seng and colleagues involved 395 women expecting their first child who were divided into four groups: those without trauma, those with a trauma but no PTSD, those with lifetime PTSD, and those with PTSD-D (presence of depersonalization and/or derealization consistent with the DSM-5 dissociative subtype definition). The researchers analyzed saliva cortisol specimens collected by these women at three different times on a single day during the first half of their pregnancy. A subsample of 111 women, including women from each of the four cohorts, provided three salivary cortisol specimens per day, 12 times, from early pregnancy to six weeks postpartum for longitudinal data (This sample included 34 women without trauma, 38 with trauma but no PTSD, 31 with PTSD only, and eight with PTSD-D).

In early pregnancy (gestational week 8), the cortisol levels of participants in the PTSD-D group were two times greater in the morning, eight times greater in the afternoon, and 10 times greater at bedtime than the cortisol levels of participants in the non-exposed control group. In late pregnancy (gestational week 32), participants in the PTSD-D group had cortisol levels that were less than two times greater in the morning and 1.5 times greater levels in the afternoon and at bedtime compared with participants in the non-exposed control group. The difference between the PTSD-D and the other groups was most apparent in early pregnancy, which is a critical period for fetal development, noted the authors.

“Although some women with histories of childhood maltreatment are resilient or recovered by the time they become pregnant, these biological findings indicate that some are very adversely affected psychologically and very stressed during the childbearing year,” the authors wrote. “We can screen and apply a stepped approach to maternity care that includes case-finding and interventions for women with PTSD, posttraumatic depression, and PTSD-D.”

For related information, see the Psychiatric News article “Researchers Tackle Complexity of Intergenerational Stress Transmission.”

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Friday, December 8, 2017

APA Paper Describes How Psychiatrists Can Improve Health of SMI Patients

Psychiatrists should routinely screen patients with serious mental illness (SMI) for common medical conditions, counsel them on lifestyle modifications to reduce cardiovascular risk factors, and coordinate with their primary care physicians to narrow the longevity gap between this group and the general population. These were some of the conclusions in a white paper that APA issued yesterday at a Capitol Hill briefing.

More than a decade has passed since researchers found that people with SMI treated in the public mental health system are dying on average 25 years earlier than the general population. “The majority of these deaths are due to untreated medical issues,” said Saul Levin M.D., M.P.A., APA CEO and medical director. “However, little progress has been made in rectifying this disparity.”

While patients with SMI often suffer from economic disadvantage and chronic stress caused by their illness, modifiable risk factors play a role as well that psychiatrists can readily address. Patients with SMI are more likely than the general population to use tobacco or other substances, have a poor diet, lead a sedentary lifestyle, and not comply with treatment regimens. These factors, coupled with the propensity for psychotropic medications to cause obesity and metabolic disorders, all contribute to the early mortality of patients with SMI. “But treatment is possible, and treatment does work,” Levin said.

Medical professionals’ bias against and stereotyping of SMI patients, particularly in the emergency department (ED), can also imperil the lives of these patients, said Glenda Wrenn, M.D. (above), director of the Kennedy-Satcher Center for Mental Health Equity at Morehouse School of Medicine in Atlanta. In fact, ED physicians list dealing with psychiatric patients as their “chief complaint” about doing their job, she said. She has seen cases in which patients with SMI died of delirium tremens because ED physicians failed to catch acute alcohol withdrawal.

Medical training for psychiatrists is often limited to medical school and a few months of internship, pointed out Benjamin G. Druss, M.D., the Rosalynn Carter Chair in Mental Health at Emory University. To keep their skills up to date, training in outpatient medical care should be provided to practicing psychiatrists in continuing medical education programs and cross-training opportunities with other medical service providers.

Ultimately, the white paper calls for more research on which models of care would best lead to the improvement of SMI patients’ physical health as well as determine the optimal role of psychiatrists in these models.

(Image: David Hathcox)

Thursday, December 7, 2017

ABPN to Pilot New Test Format as Alternative to 10-Year Proctored MOC Exam

The American Board of Psychiatry and Neurology (ABPN) is piloting a new open-book, journal article–based assessment beginning in 2019 as an alternative to the proctored 10-year Maintenance of Certification (MOC) examination.

Eligible diplomates who choose to participate in this pilot program will be required to read and answer questions on between 30 and 40 journal articles. Diplomates may choose from a library of articles that have been selected for the test by the ABPN Pilot Project Test Writing Committees. The pilot project will run for three years, from 2019-2021. If approved by the American Board of Medical Specialties (ABMS), the ABPN plans to transition diplomates into this program in 2022 as a permanent alternative to the secure MOC examination. Staff at ABPN say emailed invitations to the new testing option will be delivered next week.

Diplomates who are eligible to participate in the pilot program are those who are currently certified and who fall into one of two categories: those who have earned ABPN certification or who passed the MOC examination in the years 2012, 2013, or 2014 in psychiatry, child and adolescent psychiatry, neurology, or child neurology; or those whose certificate is expiring in 2019, 2020, or 2021 in psychiatry, child and adolescent psychiatry, neurology, or child neurology.

APA leaders said that the article-based, open-book test option is an important step in making MOC more flexible.

“Requirements around Maintenance of Certification are among the most prominent concerns of our members, and many have been asking for an alternative to the 10-year, secure, proctored exam,” APA President Anita Everett, M.D., told Psychiatric News. “APA has been advocating for something similar to the open-book journal article–based assessment, and we hope it provides an attractive option for members to consider.”

APA CEO and Medical Director Saul Levin, M.D., said the new program “provides more flexibility in terms of diplomates being able to select articles that are relevant to their own practice. It allows diplomates to read the articles and complete the test at their own pace.”

More information about the new test option will appear in an upcoming edition of Psychiatric News. Information on the program is also available on the ABPN website.

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Wednesday, December 6, 2017

Adjunctive Ketamine Appears to Reduce Suicidal Thoughts in Depressed Patients for Up to Six Weeks

A single adjunctive infusion of ketamine appears to reduce suicidal thoughts in depressed patients within 24 hours, according to a study published yesterday in AJP in Advance. This improvement was maintained for six weeks with standard, optimized pharmacotherapy.

While previous studies have suggested ketamine rapidly reduces suicidal ideation in some patients, whether similar effects would be seen in patients with major depression and high levels of suicidal ideation was less clear.

Researchers from Columbia University Medical Center and the New York State Psychiatric Institute randomly assigned 80 adults with major depressive disorder and suicidal ideation to receive ketamine or midazolam infusion. At baseline, 54% of the sample was taking antidepressant medication.

The researchers assessed the study participants’ suicidal ideation at the start of the trial using the clinician-rated Scale for Suicidal Ideation (SSI). The SSI consists of 19 items, including severity of wish to die, passive and active suicide attempts, and duration and frequency of ideation, which can be used to monitor a patient's response to interventions. This assessment was repeated 24 hours before infusion with ketamine or midazolam, 230 minutes after infusion, 24 hours after infusion, and at weeks one to six after infusion. Patients were also asked about symptoms of depression and anxiety before and after the infusion, as well as adverse effects following the infusion and again at six-week follow-up.

Within 24 hours of patients’ having received intravenous ketamine (0.5 mg/kg in 100 mL saline) or midazolam (0.02 mg/kg in 100 mL saline) infused over 40 minutes, patients in the ketamine group experienced a greater reduction in SSI score than that of the midazolam group. The proportion of patients who experienced a reduction ≥50% in their SSI score 24 hours after receiving an infusion was 55% for the ketamine group and 30% for the midazolam group. The ketamine group also experienced greater reductions in overall mood disturbance, depression, and fatigue, as measured by the Profile of Mood States, within 24 hours compared with the midazolam group.

“Longitudinal analysis of the uncontrolled six-week follow-up showed that clinical improvement after randomized and open ketamine treatment was generally maintained through six weeks of open, optimized clinical follow-up treatment with respect to SSI score and depression ratings,” Michael F. Grunebaum, M.D., and colleagues wrote.

Patients in the ketamine group experienced an increase in blood pressure and dissociative symptoms compared with patients in the midazolam group, but these adverse effects typically resolved within minutes to hours following the infusion.

“Given concerns about ketamine’s one- to two-week antidepressant effect in previous studies, it is notable that the improvement in suicidal ideation in this trial was largely maintained through the six-week follow-up ratings,” the researchers wrote. “This may be partly explained by the fact that patients continued prior psychotropic medication, which was optimized after completion of day 1 postinfusion ratings.”

For related information, see the Psychiatric News article “Analysis Finds Single-Dose Ketamine Effective for Suicidal Ideation.”

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Tuesday, December 5, 2017

New Geriatric Cognition Chart May Improve Dementia Monitoring

Researchers at Laval University in Quebec and colleagues have devised an assessment chart called QuoCo (for cognitive quotient) to track patient cognition, offering a new method they say can help identify dementia during the earliest stages. The study was published yesterday in the Canadian Medical Association Journal.

“Similar to the ‘growth charts’ that are used in pediatrics, cognitive charts allow physicians to position any patient based on age, education, and Mini-Mental State Examination [MMSE] scores, and simply track the longitudinal profile of cognitive decline over time,” wrote lead study author Patrick Bernier, M.D., Ph.D., and colleagues. Such a chart “could prompt earlier intervention for an older adult who ‘fell off’ the curve,” the authors noted.

The MMSE is commonly used to screen for dementia, but there is no consensus on how best to determine whether changes in MMSE scores over time reflect age-associated cognitive decline or represent mild cognitive impairment or dementia. Also, previous studies show MMSE cut-off scores are less reliable for some populations, particularly for older adults with less formal education.

Bernier and colleagues analyzed data from a longitudinal study of older adults known as the Canadian Study of Health and Aging. They assessed 7,569 participants aged 65 years or older who completed an MMSE at study baseline, and then 5 and 10 years later.

By comparing score results of the 6,411 participants who remained cognitively healthy during the follow-up with the 1,158 who developed dementia, while controlling for age and education, the investigators developed QuoCo scores. Similar to charts used to monitor infant growth, the researchers developed a chart that reflected optimal rates of gradual cognitive decline with age, divided into five broad percentile zones. Any patient who dropped by more than one percentile zone on the QuoCo following their initial visit was classified as having dementia.

Bernier and colleagues found that the model could distinguish healthy participants from those with dementia with a specificity of 89% and a sensitivity of 80%. The QuoCo was about 12% better overall than only using an MMSE score of 24 or less as a dementia cutoff; however, while using the cognitive charts improved the classification of patients with dementia, it also increased the misclassification of some patients with normal cognition.

To read more on this topic, see the Psychiatric News article “Dual-Task Gait Testing Identifies MCI Patients Likely to Develop Dementia.”

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Monday, December 4, 2017

Long-Term SSRI Treatment May Delay Progression From Mild Cognitive Impairment to Alzheimer’s Dementia

Long-term treatment with selective serotonin reuptake inhibitors (SSRIs) may benefit elderly patients with mild cognitive impairment (MCI) and a history of depression, even after depressive symptoms have resolved, suggested a study published in AJP in Advance.

In patients with MCI and a history of depression, long-term treatment with SSRIs (for more than four years) was associated with a delayed progression to Alzheimer’s dementia by about three years, compared with those who used SSRIs only short term or who had no treatment.

Delaying the progression from MCI to Alzheimer’s dementia would not only reduce the prevalence of Alzheimer’s disease, but also cut health insurance costs, wrote Claudia Bartels, Ph.D., of the University of Medical Center Gottingen, in Germany, and colleagues.

Bartels and colleagues analyzed data on 755 nondepressed adults aged 55 to 90 who were culled from the multicenter Alzheimer’s Disease Neuroimaging Initiative (ADNI). Participants were categorized at baseline as cognitively normal control subjects, patients with MCI, and patients with Alzheimer’s dementia and were comprehensively reassessed every six months or annually for progression from cognitively normal to MCI or Alzheimer’s dementia, or from MCI to Alzheimer’s dementia.

Of the 755 participants in the analysis, 532 were allocated at baseline to the “no history of depression–no antidepressants” group and 223 to the “history of depression” group. Of the latter group, 60 were untreated (prior depression–no antidepressants), 116 had received SSRIs (prior depression–SSRI), and 47 had received antidepressants other than SSRIs (prior depression–other antidepressants).

Statistical analysis revealed “a significantly decreased probability of conversion to Alzheimer’s dementia in MCI patients with a history of depression and long-term SSRI treatment [>1,610 days] compared with all other groups,” the authors reported. “The risk of conversion was increased in MCI patients with a history of depression and other antidepressant treatment compared with the no prior depression–no antidepressants group.” After three years of observation, however, the advantage of long-term SSRI treatment in previously depressed patients “dissolved,” researchers noted, and all groups had similar rates of progression from MCI to Alzheimer’s dementia.

The authors concluded, “Pending validation in an intervention trial, the data produced in this study may have important implications for clinical practice. … A prospective study to confirm SSRI effects on MCI progression is now warranted, as an SSRI-mediated delay may contribute to an overall lower prevalence of Alzheimer’s dementia, with a major impact on affected individuals, caregivers, public health, and health costs.”

(Image: iStock/sturti)

Friday, December 1, 2017

FDA Approves First Once-Monthly Injectable Buprenorphine for Opioid Use Disorder

The Food and Drug Administration (FDA) has approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adults who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. Sublocade is indicated for patients who have been on a stable dose of buprenorphine treatment for a minimum of seven days and is meant to be used as part of a complete treatment program that includes counseling and psychosocial support.

“Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine,” the FDA stated in a press release.

The FDA approval of Sublocade was based in part on the results of two clinical studies of 848 adults who had a diagnosis of moderate-to-severe OUD and began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval, according to Indivior Inc., manufacturer of the medication.

In a 24-week phase 3 trial, researchers randomized patients to one of the following three regimens: six once-monthly Sublocade 300 mg doses; two once-monthly Sublocade 300 mg doses followed by four once-monthly 100 mg doses; or six once-monthly injections of placebo. According to Indivior, both dosage regimens of Sublocade were shown to be superior to placebo in achieving more illicit opioid-free weeks.

“The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose-stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer interdose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose),” the agency’s press release stated.

The most common side effects of Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site, and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents under 17 years of age or adults over age of 65.

Sublocade features a boxed warning that notes the dangers of administering the drug intravenously instead of subcutaneously: “Sublocade forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including threatening pulmonary emboli, if administered intravenously.”

The medication must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients, the FDA noted.

Thursday, November 30, 2017

Insurance Company Practices Limit Access to MH Care, Finds New Report

Behavioral health providers are paid significantly less than general medical and surgical clinicians providing the same services, according to a groundbreaking report published today by Milliman Inc. The analysis, commissioned by the Bowman Family Foundation, also found that use of out-of-network services by patients is extremely high for behavioral health compared with use of general medical and surgical services.

Together, the findings paint a stark picture of restricted access to affordable and much-needed treatment for mental illness and substance use, which is particularly troublesome in an era of escalating suicide rates and opioid overdose deaths. “The result,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., “is an unequal health care system for patients with mental illness or substance use disorders.”

Milliman analyzed insurance claims data for 42 million Americans from 2013 to 2015, comparing provider reimbursement for services and use of out-of-network services in all 50 states and the District of Columbia. The analysis found that general medical and surgical providers were paid rates an average of 20% higher than those of behavioral health providers for the same office visits billed under identical or similar codes. In 2015 alone, there were 24 states with reimbursement disparities ranging from 30% to 69%.

Milliman also found extraordinary discrepancies in the use of out-of-network providers. On average, 18.7% of behavioral health office visits were accessed out of network in 2015, while just 3.7% of primary medical/surgical office visits were accessed out of network. Moreover, 16.7% of inpatient facility behavioral health care was accessed out of network compared with just 4% of inpatient facility medical/surgical care.

In 2015, out-of-network use of behavioral health inpatient care compared with that of general medical and surgical care was approximately 800% higher in California, New York, and Rhode Island and over 1000% higher in Connecticut, Florida, New Hampshire, New Jersey, and Pennsylvania.

APA leaders said that the findings are evidence of a pattern of behavior by insurance companies that is forcing patients into costly out-of-network care. The result is that many patients have limited access to care and may abandon treatment altogether because they cannot afford it. In addition, the findings point to potential violations of federal and state parity laws, which require insurance companies to cover treatment for mental illness and substance use at the same levels as for other medical illnesses.

“This report echoes what APA has been saying for the past several years—that insurers are not maintaining adequate networks of mental health providers for patients and that psychiatrists are reimbursed less than primary care doctors for the same services,” Levin said. “We call upon state and federal regulators to ensure that insurance companies are abiding by parity laws already on the books.” 

For related information, see the Psychiatric News article “Enforcement of Parity Law Broadens to Include New Areas of Insurer Violations.

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Wednesday, November 29, 2017

Substance Use-Induced Psychosis Highly Correlated With Later Schizophrenia, Bipolar Disorder

As many as a third of all patients with substance use-induced psychosis may go on to develop schizophrenia or bipolar disorder within five years, according to a report published yesterday in AJP in Advance. The highest risk of conversion to either schizophrenia or bipolar disorder was for patients who experienced cannabis-induced psychosis, which had a conversion rate of 47.4%.

The findings suggest the need for early identification and rapid treatment. “It is important to diagnose new cases of schizophrenia and bipolar disorder as soon as possible and to initiate treatment without delay, because prolonged psychosis without treatment is associated with a worse prognosis,” wrote Marie Stefanie Kejser Starzer, M.D., and colleagues at Copenhagen University Hospital.

Starzer and colleagues analyzed data from the Danish Psychiatric Central Research Register, which has registered all inpatient psychiatric treatment since 1969 and outpatient treatment since 1995.

The study population consisted of 6,788 patients who received a diagnosis of substance-induced psychosis over a 20-year period and who did not have any previous record of treatment for schizophrenia spectrum disorders or bipolar disorder. Ten comparison subjects were selected for each case subject, matched on sex, year, and month of birth, and being alive at the date of the incident substance-induced psychosis of the corresponding case subject.

The case subjects were followed up from incident substance-induced psychosis, and comparison subjects from their corresponding match date, until the first occurrence of schizophrenia or bipolar disorder or until death, migration, or Aug. 14, 2014, whichever came first.

A total of 32.2% of all patients with substance use-induced psychosis converted to either schizophrenia or bipolar disorder. In addition to cannabis use, self-harm after a substance-induced psychosis was significantly linked to a higher risk of converting to both schizophrenia and bipolar disorder. Young age was associated with a higher risk of conversion to schizophrenia; the risk was highest for those in the range of 16 to 25 years.

Fifty percent of conversions to schizophrenia occurred within 3.1 years, and 50% of conversions to bipolar disorder occurred within 4.4 years.

“Based on the different risk factors identified in different analyses and the overall conversion rate of 32.2%, it seems most reasonable to suggest that all patients with a substance-induced psychosis should be offered follow-up,” the authors stated. Follow-up from incidence of substance-use induced psychosis should be at least two years, they wrote.

For related information, see the Psychiatric News article “Cannabidiol May Benefit Patients With Early Psychosis, Cannabis Misuse.”

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Tuesday, November 28, 2017

Denying Certain Requests May Reduce Patient Satisfaction

Patient satisfaction is acknowledged as an important part of patient-centered care; however, some controversy exists regarding how honoring patients’ requests fits into this paradigm. A study published yesterday in JAMA Internal Medicine found that denial of several types of patient requests is associated with lower patient-satisfaction ratings of the physician. Specifically, denials of requests for referral, pain medication, other new medications, and laboratory tests were associated with significantly worse patient satisfaction.

“In an era of satisfaction score–driven compensation of clinicians, the findings suggest the need to explore the utility of training clinicians to better handle patient requests, potentially optimizing the patient experience while also enhancing clinician career satisfaction,” Anthony Jerant, M.D., and colleagues at the University of California Davis School of Medicine, Sacramento wrote.

For the study, Jerant and colleagues asked 1,141 patients to rate their satisfaction immediately after 1,391 office visits with 56 family physicians. Patient satisfaction was measured using a scale composed of six items from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Adult Visit Survey, which included questions about whether the patients felt the physician communicated in a way they could understand, spent enough time with them, and whether they would be likely to recommend the physician to their family and friends.

Study participants were also asked whether during the appointment they had made requests for the following services and, if so, whether they perceived that the physician had fulfilled or denied these requests: referral to another clinician; new medications; or follow-up tests, including laboratory and radiology tests.

Among 1,319 visits, 897 (68.0%) included at least one request; 1,441 (85.2%) were fulfilled. Compared with fulfillment of a request in the respective category, denials of requests for pain medication, referral, other new medication, and laboratory tests were associated with a significantly worse patient satisfaction rating of the physician. In contrast, denials of requests for antibiotics and referrals for imaging tests were not associated with worse patient satisfaction.

“[I]t is no coincidence that antibiotic prescription and imaging test referral were not associated with lower satisfaction,” JAMA Internal Medicine Associate Editor Joseph S. Ross, M.D., M.H.S., wrote in a comment reflecting on the findings. He noted that “substantial attention has been devoted to preparing physicians to avoid frequently requested, low-value care such as these. We can train physicians to say no to other types of clinically inappropriate requests, while still reassuring patients and paying attention to their needs.”

For related information, see the Psychiatric Services article “Association Between Quality Measures and Perceptions of Care Among Patients With Substance Use Disorders.”

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Monday, November 27, 2017

Saliva Biomarkers May Help Predict Post-Concussion Syndrome in Youth

Biomarkers in saliva may help identify youth who are likely to take more time to recover following a concussion, according to a study published in JAMA Pediatrics.

Steven Hicks, M.D., Ph.D., and colleagues at Penn State College of Medicine found that measuring the salivary levels of five microRNAs (miRNAs)—small, noncoding RNA molecules that influence protein production throughout the body—can identify children with post-concussion syndrome (PCS) with about 85% accuracy. In comparison, the Sport Concussion Assessment Tool (SCAT3), the tool currently used to determine PCS, was about 65% accurate.

“The miRNAs associated with PCS have potential utility as a toolset for facilitating concussion management,” Hicks and colleagues wrote. “This tool could ease parental anxiety about expected symptom duration. An objective PCS tool could also inform clinical recommendations about return-to-play and school-based accommodations.”

Hicks and his team took saliva samples and performed SCAT3 assessments on 52 youth aged 7 to 21 who had recently had a concussion. The participants were re-evaluated with SCAT3 after four weeks, and patients with symptom scores of 5 or more were designated as having PCS; 30 of the participants met the criteria for PCS.

The researchers analyzed over 400 miRNAs from the patient saliva samples and identified 15 miRNA that were expressed differently among youth with and without PCS. With additional analysis, the researchers narrowed in on a set of five miRNAs (miR-320c-1, miR-133a-5p, miR-769-5p, let-7a-3p, and miR-1307-3p) that proved the most accurate at distinguishing patients with PCS from patients whose symptoms resolved.

In addition, elevated levels of three miRNAs were individually associated with specific PCS symptoms. MiR-320c-1 was associated with memory difficulty, miR-629 was associated with headaches, and let-7b-5p was associated with fatigue.

“To our knowledge, no single biomarker or biomarker panel has demonstrated adequate test characteristics to be widely used as an objective measure for diagnosing or monitoring recovery from a concussion or for predicting those who are at highest risk for a prolonged recovery,” wrote William Meehan III, M.D., and Rebekah Mannix, M.D., M.P.H., in an accompanying editorial. “If validated in larger, multisite clinical trials, using this salivary microRNA panel to diagnose and manage concussions could be a major advancement to the field.”

For related information, see the Psychiatric News article “Could Changes in Tau Predict Recovery Following Sport-Related Concussion?

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Wednesday, November 22, 2017

Study Highlights Need for PTSD Interventions for Cancer Patients

Research on adult cancer patients in Southeast Asia found a striking prevalence of posttraumatic stress disorder (PTSD), with about 1 in 5 (21.7%) experiencing symptoms of PTSD six months after being diagnosed with cancer. The study was published Monday in Cancer.

Although participants’ rates of PTSD declined with time, the data underscore the risk of developing persistent PTSD even years after cancer diagnosis and treatment, according to the authors of the study. About one-third of patients (34.1%) initially diagnosed with PTSD or some of its symptoms went on to develop chronic or worsening PTSD four years later. 

“There is a need for early identification of this subset of patients who have cancer with PTSD to design risk-targeted interventions,” concluded Caryn Mei Hsien Chan, Ph.D., of the National University of Malaysia in Kuala Lumpur and colleagues. 

Moreover, finding ways to monitor PTSD among patients living with cancer is critical because many of its symptoms, such as avoidance and cognitive difficulties, are enduring, which may potentially impact adherence to treatment, the authors noted. 

The study involved face-to-face interviews with 469 patients within one month of cancer diagnosis. Participants took the Hospital Anxiety and Depression Scale (HADS) at the outset and four weeks to six weeks later. Those who were found to have psychological distress underwent the PTSD module of the Structured Clinical Interview for DSM-IV (SCID) at six months. At the four-year follow-up, the SCID was used to assess PTSD in all 245 living patients, regardless of their HADS scores. 

The high rate of PTSD found in the study may be partly due to the higher risk of PTSD found in Asian patients with cancer, compared with patients of Caucasian descent, the researchers wrote. The researchers also included so-called “subsyndromal” PTSD cases: patients whose symptoms lasted less than one month or who did not meet the threshold for a DSM-IV diagnosis despite the presence of multiple symptoms.

The study also found that patients with breast cancer were 3.68 times less likely to have PTSD at the six-month follow-up than those with other types of cancer, but not at the four-year follow-up. “Because breast cancer is a very common malignancy, it is possible that greater societal understanding and the wider availability of support programs tailored for breast cancer (compared with fewer support programs for patients with other cancer types) initially serve as protective factors against PTSD,” the authors wrote.

For related information, see the Psychiatric News article “Mental Health Issues in Cancer Survivors Persist Long After Treatment Ends.”

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Tuesday, November 21, 2017

Long-Term Treatment of Tardive Dyskinesia With Valbenazine Appears Safe, Effective

Long-term treatment with valbenazine for tardive dyskinesia (TD) appears to be safe and well-tolerated while maintaining treatment effects seen in an earlier short-term trial, according to a report in the Journal of Clinical Psychiatry

In April, the Food and Drug Administration approved Ingrezza (valbenazine) capsules to treat adults with TD—a serious side effect associated with chronic use of antipsychotics—making it the first FDA-approved product for the condition. This approval was based in part on the results of a six-week trial, 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. As was reported in the American Journal of Psychiatry (May 2017), treatment with valbenazine resulted in a significant reduction in patients’ Abnormal Involuntary Movement Scale (AIMS) dyskinesia score compared with placebo.

In the current study, Stuart A. Factor, D.O., of Emory University and colleagues tracked the long-term outcomes of 198 patients who entered a 42-week valbenazine extension period following the initial six-week trial. Safety assessments included treatment-emergent adverse events (TEAEs) and scales for suicidal ideation/behavior, treatment-emergent akathisia or parkinsonism, and psychiatric symptoms. Efficacy assessments included the AIMS and Clinical Global Impression of Change-Tardive Dyskinesia.

Of the 198 patients who entered the valbenazine extension period, 124 (62.6%) completed the 42-week treatment. During the extension period, 69.2% of participants had more than one TEAE, but the only events leading to study discontinuation in more than two participants were somnolence (n=3) and suicidal ideation (n=3). (The cases of suicidal ideation were treated and deemed to be unrelated to valbenazine, according to the report.) The incidence of “serious” TEAEs was 14.6 percent, with syncope the only serious TEAE reported in more than two participants.

TD improvement with valbenazine was sustained throughout the extension period, with statistically significant improvements relative to baseline in both dose groups. During a four-week washout period following discontinuation of valbenazine, AIMS scores increased, indicating that TD symptoms tended to return to baseline. The findings suggest that ongoing valbenazine treatment may be required to maintain TD improvements, according to the authors.

“Results of this extension study generally indicated that valbenazine was safe and well tolerated, and maintenance of treatment effect was apparent for both doses,” the authors wrote. “Further research is needed to better understand the long-term effects of valbenazine on TD and to identify the types of patients who might benefit most from this novel medication.”

For related information, see the Psychiatric News story “The Valbenazine Story: Small Company Makes Big Breakthrough.”

Tell Congress: Tax Cuts Shouldn't Hurt Patients

Congress is forging ahead with passing major tax reform that threatens patients' access to health care. The House-passed proposal takes away the medical expense deduction that helps some patients pay for their appointments, stays in inpatient psychiatric or substance use facilities, and medications. The Senate’s proposal calls for the repeal of the Affordable Care Act’s individual mandate, which would cause the number of uninsured Americans to increase by an estimated 13 million by 2027 and ultimately result in skyrocketing premium increases. 

The Senate is expected to vote on their reform package the first week of December. That means there is time for you to voice your opposition to tax reform proposals that harm access to mental health care. Write your federal lawmakers today!

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Monday, November 20, 2017

Hormonal Contraception May Increase Risk of Suicide, Study Suggests

Women who use hormonal birth control may be more likely to attempt or die by suicide than those who never use the medication, according to a study of women aged 15 to 33 in Denmark. The findings were published in AJP in Advance.

“Adolescent women experienced the highest relative risk,” wrote Charlotte Wessel Skovlund, Ph.D., and colleagues of the University of Copenhagen. “Patch, vaginal ring, and progestin-only products were associated with higher risks than oral combined [estrogen and progestin] products, and a similar association was suggested for suicide.”

To assess associations between their use of hormonal birth control and the risk of a first suicide attempt or suicide, Skovlund and colleagues followed a national cohort of Danish women who turned 15 during the study period, which extended from 1996 to 2013, and who had no history of hormonal contraceptive use. Women with prior suicide attempts, antidepressant use, and psychiatric diagnoses were excluded from the analysis.

The study included nearly half a million women followed on average for 8.3 years with a mean age of 21 years. A total of 6,999 first suicide attempts and 71 suicides were identified. The association between hormonal birth control and a first suicide attempt peaked after two months of use. 

Compared with women who never used hormonal birth control (“never users”), users of hormonal birth control aged 15 to 33 years had a relative risk of 1.97 for a first suicide attempt and 3.08 for suicide. The relative risk of a first suicide attempt increased rapidly after initiation of hormonal contraception use, compared with never use, and it remained at least doubled until one year after initial use. 

Following that, the risk estimates decreased, but remained higher compared with never users after more than seven years of use. The relative risk of suicide attempt with hormonal contraceptive use was for 2.06 for the 15-19 age group, 1.61 for the 20-24 age group, and 1.64 for the 25-33 age group.

“Our data indicate that adolescent women are more sensitive than older women to the influence of hormonal contraceptive on risk of a first suicide attempt,” the authors wrote. This age difference may be due to the fact “adolescent women are particularly vulnerable to risk factors for suicide attempt,” they noted.

They concluded, “Considering the severity of these little-recognized potential side effects of hormonal contraceptives, health professionals and women starting hormonal contraceptives should be informed about them.”

For related information, see the Psychiatric News article “Increased Risk of Depression Tied to Some Contraceptive Use.”

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Friday, November 17, 2017

FDA Expands Indication of Electric Stimulation Device to Treat Opioid Withdrawal Symptoms

The Food and Drug Administration (FDA) has approved the use of an electric stimulation device to help to reduce the symptoms of opioid withdrawal, marking the first time a device has been indicated for withdrawal symptoms.

The NSS-2 Bridge is a small device placed behind the patient’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment,” said FDA Commissioner Scott Gottlieb, M.D., in a press announcement. “While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy.”

The FDA marketing approval was granted based on an open-label pilot study of the effects of the nerve stimulator on 73 patients undergoing opioid physical withdrawal. The study found that the average clinical opiate withdrawal scale (COWS) scores of the participants dropped by about 63% after 20 minutes of use, and 85% after 60 minutes. After five days of use, 64 of the 73 participants (88%) successfully transitioned to medication-assisted treatment (MAT). Successful transition to MAT was defined as “those who returned to the clinic and received their first dose of maintenance medication,” the study authors noted in a report published in March in the American Journal of Drug and Alcohol Abuse.

The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway that fast-tracks low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can be compared. The device was developed by Innovative Health Solutions Inc., and was cleared by the FDA in 2014 for use in acupuncture.

To read more about this topic, see the Psychiatric News article “FDA Clears First Prescription-Based ‘Digital Therapeutic.”

Thursday, November 16, 2017

APA, Five Other Medical Groups Voice Opposition to Senate Proposal to Remove Individual Mandate

Repeal of the mandate under the Affordable Care Act (ACA) to buy health insurance is likely to raise premiums and increase the number of uninsured Americans, APA and five other medical specialty organizations said in a statement released today responding to provisions in the Senate tax reform bill that would eliminate the mandate.

“The Congressional Budget Office (CBO) estimates that repeal of the individual mandate will result in 13 million people becoming uninsured by 2027,” APA and the five other groups said. “Furthermore, repealing the mandate will increase premiums and destabilize the individual and small group markets.”

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

The so-called “individual mandate” requires individuals not otherwise covered by health insurance to buy insurance in the ACA health exchanges or pay a tax penalty. Advocates say that without the mandate to buy health insurance, only the sick would enroll, causing adverse selection and destabilization of insurance markets.

“Our members are the nation’s frontline physicians, providing care to individuals and families in communities large and small, urban and rural,” the groups stated. “They see each day the inherent value of having health care coverage. Health care coverage is the gateway to prevention and wellness and a guardrail in the event of a major health event. Having health care coverage and a continuous relationship with a physician are the two factors that have been proven the world over to increase quality and decrease cost.

“Additionally, increased access to affordable health care coverage is a major reason that bankruptcies related to health care have decreased significantly over the past five years. Health care coverage provides financial security to millions of people and protects them in the most challenging times of their life, especially those that have pre-existing conditions and conditions that require a high intensity of care over their lifetime.

“Our organizations oppose provisions in the Senate tax reform proposal that would repeal policies requiring individuals to purchase health care coverage,” they continued. “Our health care system needs improvements, and our organizations stand ready to work with the Senate to identify bipartisan and impactful reforms that will ensure a robust and competitive health care market. However, according to the Congressional Budget Office, repeal of the individual mandate in this form, absent additional reforms that would stabilize the insurance market, has the potential to raise health insurance premiums by a projected 20 percent and increase the number of uninsured Americans.”

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Wednesday, November 15, 2017

Naltrexone, Buprenorphine-Naloxone Found Equally Effective in OUD Patients Who Initiate Treatment

Extended-release naltrexone and sublingual buprenorphine-naloxone appear to be equally safe and effective at preventing opioid relapse in patients with opioid use disorder (OUD). However, it can be harder to initiate patients actively using opioids on naltrexone (due to required detox period) than buprenorphine-naloxone. These two findings were reported in a study published yesterday in The Lancet.

“Both medications are effective treatments for opioid use disorders versus counseling-only approaches or compared to placebo. What is now clear is how similar the outcomes are for those initiating treatment with either medication,” Joshua D. Lee, M.D., M.Sc., of NYU School of Medicine said in a press release. “Patients wanting naltrexone but who are unable to complete detox should be encouraged to start an agonist-based treatment like buprenorphine.”

Naltrexone (an opioid μ-receptor antagonist) differs from buprenorphine both in terms of induction and ongoing care. The medication cannot be initiated until patients are fully detoxified without risking precipitated withdrawal, but once initiated, naltrexone produces no opioid-like effects and no physiological dependence. In contrast, buprenorphine (a partial agonist) can be initiated as soon as patients are in mild-to-moderate withdrawal. Unlike naltrexone, buprenorphine maintains physiological opioid dependence, and withdrawal is likely to occur on discontinuation.

Lee and colleagues randomly assigned 570 patients with OUD to receive monthly injections of extended-release naltrexone (brand name Vivitrol) or daily buprenorphine-naloxone (brand name Suboxone) for 24 weeks. Study participants were 18 years or older and had used non-prescribed opioids in the past 30 days. Unlike patients in the buprenorphine-naloxone group, who received medication shortly after randomization, those assigned to naltrexone had to complete detoxification before receiving the first injection of medication. Detoxification was defined as not using an opioid for three or more days, having urine that tested negative for opioids, and having a negative naloxone challenge.

As expected, fewer patients successfully initiated naltrexone compared with buprenorphine/naloxone (72% versus 94%). Of the 474 patients who successfully began treatment, the proportion of opioid-relapse events over the course of the study was similar (52% for the naltrexone group versus 56% for the buprenorphine/naloxone group). The proportion of participants reporting adverse events and serious adverse events did not differ between the groups, with the exception of reactions at the injection site of naltrexone, all of which were of minor to moderate severity.

“Studies show that people with opioid dependence who follow detoxification with no medication are very likely to return to drug use, yet many treatment programs have been slow to accept medications that have proven to be safe and effective,” Nora D. Volkow, M.D., director of the National Institute on Drug Abuse, said in a press release. “These findings should encourage clinicians to use medication protocols, and these important results come at a time when communities are struggling to link a growing number of patients with the most effective individualized treatment.”

For related information, see the Psychiatric News PsychoPharm article “Psychiatrists Discuss Risks, Benefits of Medications for Opioid Use Disorder.”

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