Wednesday, December 31, 2014

Teens With and Without Elevated Suicide Risk Have Equal Access to Guns, Study Shows

Despite recommendations to limit access to guns for people with risk factors for suicide, adolescents with and without a recent or lifetime history of suicidality are equally likely to live in homes with access to a firearm, according to a study published online yesterday in JAMA Psychiatry.

The National Comorbidity Survey—Adolescent Supplement questioned 10,123 adolescents from 2001 to 2004 and found that 29% reported a firearm in the house, and about one-third of that group said they had easy access to and an ability to fire the weapon, wrote Joseph A. Simonetti, M.D., M.P.H., of the Department of Medicine and the School of Public Health at the University of Washington and the Veterans Affairs Puget Sound Health Care System in Seattle and colleagues.

A little over half (54%) of adolescents with firearms access met lifetime criteria for a mental disorder compared 49% of those with a mental disorder but without firearm access. However, the researchers said, “a greater proportion of those with access had a recent history of alcohol abuse (8.2% vs. 2.9%), a lifetime history of alcohol abuse (10.1% vs. 3.8%), and a lifetime history of drug abuse (11.4% vs. 6.9%)”—all factors found at higher rates among those who die by suicide.

Parents may not be aware that children have access to a gun or that access is a mitigable risk factor for suicide, suggested the authors, who stressed that “[F]urther attention to developing and implementing evidence-based strategies to decrease firearm access among adolescents is warranted.”

For more in Psychiatric News about addressing firearm safety in medical visits, see "Court Upholds Ban on Doctors Discussing Gun Ownership."

(Image: WongWeAn/

Tuesday, December 30, 2014

Study Finds Olanzapine-Fluoxetine Combo Superior to Placebo for Bipolar Disorder in Children

A combination of the antipsychotic olanzapine and the antidepressant fluoxetine proved superior to placebo for acute treatment of bipolar I depression in patients aged 10-17 in a randomized control trial published online in the Journal of the American Academy of Child and Adolescent Psychiatry.

The double-blind study by researchers at Eli Lilly and Company randomized 170 young patients with bipolar I disorder experiencing an acute depressed episode to the olanzapine/fluoxetine combination (OFC) and 85 to placebo for up to eight weeks of treatment. The primary efficacy measure was mean change in the Children’s Depression Rating Scale-Revised (CDRS-R).

Baseline-to-week-8 least-squares mean change in CDRS-R score was greater for OFC-treated patients than for placebo-treated patients, with between-group differences statistically significant at week 1 and all subsequent visits. Rates of and times to response and remission were statistically significantly greater for OFC- than placebo-treated patients. The most frequent treatment-emergent adverse events in the OFC group were weight gain, increased appetite, and somnolence. Treatment-emergent hyperlipidemia was common among OFC-treated patients.

“OFC was superior to placebo and approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of bipolar I depression in patients 10-17 years of age. Benefits should be weighed versus the risk of adverse events, particularly weight gain and hyperlipidemia,” the researchers said.

To read more about research on child and adolescent bipolar disorder, see the Psychiatric News article, "Link Found Between Glutamate, Adolescent Bipolar Disorder."

(Image: Blade Tucker/

Monday, December 29, 2014

FDA Approves New Alzheimer's Medication

The Food and Drug Administration approved the New Drug Application for Namzaric to treat moderate to severe Alzheimer’s. Namzaric is a fixed-dose combination of extended-release memantine hydrochloride, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

These two medications are often co-prescribed for Alzheimer’s patients, and a recent clinical study demonstrated that giving memantine to patients already taking acetylcholinesterase inhibitors could boost improvements in cognition and functioning, with minimal adverse effects.

This new dual-formula drug will reduce the number of pills Alzheimer’s patients need to take daily; the capsule can also be opened and the drug sprinkled on food for patients who have difficulty swallowing.

Namzaric was developed by Actavis along with partner Adamas Pharmaceuticals and is expected to be launched in the U.S. sometime in the second quarter of 2015.

To learn how antidepressants may also someday help in the fight against Alzheimer’s, see the Psychiatric News article “Antidepressant Reduces Amyloid Load, Study Finds.”

(shutterstock/Hurst Photo)

Wednesday, December 24, 2014

Long-Term Study Assesses Fetal Alcohol Syndrome Outcomes in Adults

A Swedish population study finds that that many of the educational, employment, health, and other outcomes for 79 adults diagnosed as children with fetal alcohol syndrome (FAS) were different from those of a matched comparison group of 3,160 people, said Jenny Rangmar, Ph.L, a doctoral candidate at Gothenburg University, and colleagues in the January Pediatrics.

For instance, the FAS group (average age, 32) were more likely to have received a disability pension (31 percent vs. 3 percent), to have received special education (25 percent vs. 2 percent), and to have higher hospital admission rates for psychiatric disorders (33 percent vs. 5 percent).

However, rates of criminal conviction were slightly but not significantly higher for the FAS group and were actually lower than a subset of the comparison group that had been placed in state care. Of those who did receive special education, about 60 percent completed high school, suggesting some disabilities “may be ameliorated by protective factors like special education and assistance in school.” Finally, 49 percent of FAS subjects were employed, although probably in lower-paying jobs than their peers, the researchers noted.

These results may have been influenced by an early diagnosis of FAS, providing “a protective effect because it may give children benefit from appropriate services,” said Rangmar and colleagues.

To read more about studies of fetal exposure to substances of abuse, see the Psychiatric News article “How Do Abused Drugs Affect Fetus, Newborn?

(Image: ChameleonsEye/

Tuesday, December 23, 2014

CBT For Children With Anxiety May Confer Long-Term Suicide Prevention Benefit, Study Suggests

Successful cognitive-behavioral therapy (CBT) for childhood anxiety disorder may confer long-term benefits for suicide prevention, according to a report in the Journal of the Academy of Child and Adolescent Psychiatry.

Evidence for an independent relationship between anxiety and suicidality has been mixed. Researchers from the Center for Mental Health Policy and Services Research at the University of Pennsylvania Perelman School of Medicine examined the relationship between response to treatment for an anxiety disorder in childhood and suicidal ideation, plans, and attempts at a follow-up interval of seven to 19 years. In the study, 66 adults were assessed, having completed CBT treatment for anxiety as children. Information regarding suicidality at follow-up was obtained via the World Mental Health Survey Initiative Version of the World Health Organization Composite International Diagnostic Interview and the Beck Depression Inventory.

The follow-up data indicated that participants who responded favorably to CBT during childhood were less likely to endorse lifetime, past-month, and past-two-week suicidal ideation than were treatment nonresponders. This was consistent across self-report and interview-report of suicidal ideation.

“Results suggest more chronic and enduring patterns of suicidal ideation among those with anxiety in childhood that is not successfully treated,” the researchers stated. “This study adds to the literature that suggests successful CBT for childhood anxiety confers long-term benefits and underscores the importance of the identification and evidence-based treatment of youth anxiety.”

For more on research into suicide prevention, see the Psychiatric News article, "Novel Suicide-Prevention Treatment Targets Poor Sleep."

(Image: Sabphoto/

Monday, December 22, 2014

Benzodiazepine Prescriptions High Among the Elderly, Study Finds

A new surveillance study has found that benzodiazepine usage increases with age, with nearly 9 percent of adults aged 65 to 80 filling a benzodiazepine prescription in 2008, compared with around 7 percent of adults 51 to 64, 5 percent of adults aged 36 to 50, and less than 3 percent of adults aged 18 to 35.

Adults over 65 were also more likely to have a long-term prescription for a benzodiazepine and were more likely to have their prescription written by a nonpsychiatrist; psychiatrists wrote less than 6 percent of benzodiazepine prescriptions for those aged 65 to 80.

These findings were published in JAMA Psychiatry on December 17.

Benzodiazepines can be effective in the short-term for treating anxiety or insomnia, but their risk of dependence and adverse effects such as cognitive impairment and loss of balance has led to expert recommendations to limit their use, especially in elderly people.

“It was alarming to find the highest rates of benzodiazepine use among the group with the highest risks,” said study author Michael Schoenbaum, Ph.D., of the Office of Science Policy, Planning, and Evaluation at the National Institute of Mental Health. “Given that safer, effective options are available for anxiety and insomnia, it’s hard to make a clinical argument for these results.”

Schoenbaum proposed that clinicians should restart a dialogue on the usage of benzodiazepines in the elderly, though a commentary accompanying the study suggested even stronger changes.

“It may be time to act, perhaps first by restricting the prescription of benzodiazepines to psychiatrists. In the study, psychiatrists seemed to prescribe them properly. The next step is to consider them the same as other dangerous addictive substances and put them on a tight dispensation schedule using limited-duration prescriptions with no refills,” the commentary authors wrote.

To read about the potential cognitive harm of benzodiazepine use, see the Psychiatric News article "Long-Term Use of Benzodiazepines May Be Linked to Alzheimer’s.

(shutterstock/khemporn tongphay)

Friday, December 19, 2014

Hyperactivity of Caudate Nucleus May Be An Underlying Factor of OCD Symptoms, Study Finds

A study published in today’s American Journal of Psychiatry suggests that misfiring of the brain’s control system for habits may be a reason for compulsions in obsessive-compulsive disorder (OCD).

Researchers in the departments of psychiatry and psychocology at Cambridge Behavioural and Clinical Neuroscience Institute and New York University performed MRI scans on the brains of 70 people, with and without OCD, to determine whether an association existed between symptoms of OCD and abnormal brain activation in the caudate nucleus, a structure in the basal ganglia that must fire correctly for one to control their habits. While receiving scans, the patients were asked to press a pedal, a part of a pedal pressing behavioral test, to avoid shock to the wrist. In the final stage of testing, the shock block was removed to assess whether the pedal-pressing behaviors of the patients could be discontinued.

The researchers found that patients with OCD were less capable of stopping their pedal-pressing habits than the control group. In addition, individuals in the OCD cohort were more likely to have hyperactivation in the caudate nucleus, compared with those without OCD.

The study’s lead author, Claire Gillian, Ph.D., a professor of psychology at the New York University, stated that the findings may not be specific to OCD and that in fact habits may underpin symptoms of many psychiatric conditions. “There are a range of human behaviors that are now considered examples of compulsivity, including drug and alcohol abuse and binge eating. What all these behaviors have in common is the loss of top-down control, perhaps due to miscommunication between regions that control our habits and those such as the prefrontal cortex that normally help control volitional behavior. As compulsive behaviors become more ingrained over time, our intentions play less and less of a role in what we actually do,” she concluded.

To read about other studies investigating possible pathophysiologies of OCD, see the Psychiatric News article “Study Looks at Association Between OCD, Schizophrenia.”

(Image: Fedorov Oleksiy/

Thursday, December 18, 2014

Preliminary Study Shows Primary Care Provider Training Can Improve Prescribing for Children

A New York state initiative to provide psychiatric consultation to pediatric primary care providers about prescribing psychotropic medication shows promise for enhancing providers' comfort with prescribing, according to the report “Detection and Treatment of Mental Health Issues by Pediatric PCPs in New York State: An Evaluation of Project TEACH” published online in Psychiatric Services in Advance.

Researchers in the Department of Child and Adolescent Psychiatry at New York University School of Medicine and colleagues at other institutions evaluated Project TEACH (PT), a statewide training and consultation program for pediatric primary care providers (PCPs) on identification and treatment of mental health conditions. The project is part of a collaboration between the REACH Institute (Resource for Advancing Children’s Health) and five academic departments of psychiatry. The curriculum consists of 15 hours of in-person training, a tool kit, and Web-based learning tools, along with a six-month distance learning program that includes 12 one-hour consultation calls with child psychiatrists.

Researchers compared an intervention group of 176 PCPs who volunteered for PT training with a stratified random sample of 200 PCPs who did not receive PT training. Data on prescription practices, diagnoses, and follow-up care were from New York State Medicaid files for youths seen by the trained and untrained PCPs. They found that the percentage of children prescribed psychotropic medication increased after PT training (from 9% to 12%), a larger increase than in the untrained group (from 4% to 5%).

“Our findings suggest potential benefits of training PCPs to identify and treat children’s mental health conditions," the researchers said. "Provider training and consultation may be a meaningful way to help reduce the number of children who do not receive treatment for mental health conditions, but further research is necessary to determine whether this type of model will be useful as the responsibility for mental health care and outcomes shifts under health care reform.”

For more about this program, see the Psychiatric News article, "New York Child Psychiatry Divisions Fill Gap in Collaborative Care Model."

(Image: Lisa F. Young/

Wednesday, December 17, 2014

Health Coaching Intervention Effective for Obesity in Those With Serious Mental Illness, Study Finds

A health coaching intervention for obesity appears to be effective in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese individuals with serious mental illness.

That’s the finding of a replication trial of the In SHAPE program in the report “Pragmatic Replication Trial of Health Promotion Coaching for Obesity in Serious Mental Illness and Maintenance of Outcomes,” published in AJP in Advance.

In SHAPE is a 12-month program consisting of individual weekly meetings in the community with a health-promotion coach, a fitness club (YMCA) membership, and nutrition education adapted for people with serious mental illness that was found in a previous study to contribute to clinically significant reduction in cardiovascular risk in overweight or obese adults with serious mental illness.

In the new study, Stephen Bartels, M.D., of the Department of Psychiatry and the Dartmouth Institute for Health Policy and Clinical Practice at the Geisel School of Medicine at Dartmouth and colleagues randomly assigned 210 individuals with serious mental illness and a body mass index greater than 25 receiving services in three community mental health organizations either to the 12-month In SHAPE program or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test) assessed at baseline and at 3, 6, 9, 12, and 18 months.

At 12 months, the In SHAPE group had greater reduction in weight and improved fitness compared with the fitness club membership group. Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group achieved clinically significant cardiovascular risk reduction, defined by a weight loss greater than 5 percent or an increase of greater than 50 meters on the 6-minute walk test.

“By comparing In SHAPE to an active comparison condition (a fitness club membership), we were able to test the specific contribution of having a health-promotion coach,” the researchers stated. “Having a health-promotion coach was associated with more than two-and-a-half times the mean amount of fitness club attendance, which in turn was associated with greater weight loss and improved fitness.”

For more on this subject, see the Psychiatric News article, "Health Mentors Prove Valuable For Those With Serious Mental Illness."

(Image: Shutterstock)

Tuesday, December 16, 2014

Senator Blocks Passage of Veterans' Suicide Prevention Bill

The legislative battle went down to the wire, but a lone recalcitrant senator ultimately blocked passage of a bill to help reduce suicides among veterans by enabling the Veterans Health Administration (VHA) to hire more psychiatrists. APA, veterans’ service organizations, and the Department of Veterans Affairs had strongly backed the Clay Hunt Suicide Prevention for American Veterans Act, which the House of Representatives approved unanimously last week.

The Senate vote was blocked by a “hold” placed on the bill by retiring Sen. Tom Coburn (R-Okla.), who objected to the allegedly dysfunctional management of the VHA. A hold permits a single senator to block a vote on the Senate floor.

In reply, Sen. Richard Blumenthal (D-Conn.) noted that the act included provisions for annual evaluations of the VHA’s mental health care and suicide prevention programs, in addition to encouraging recruitment of “not less than 10” psychiatrists per year into the VHA in part through use of a medical school loan repayment program. Psychiatrists entering the program would agree to a minimum of two years of service with the VHA in return for a $30,000 per year loan repayment.

There is hope for passage early next year, however. “Veterans groups have assurances from Senators John McCain (R-Ariz.) and Richard Burr (R-N.C.) for a quick reintroduction in January,” said Lizbet Boroughs, deputy director of APA’s Department of Government Relations. “A bipartisan group of 20 senators currently supports the bill, and Representatives Jeff Miller (R-Fla.) and Tim Walz (D-Minn.) will act quickly on the House side, as well.”

For more in Psychiatric News about psychiatrists and mental health care in the VHA, see the article “Psychiatrists’ Pay to Rise at Veterans Health Administration.”

(Image: Susan Montgomery/

Monday, December 15, 2014

Patients Should Know Their Rights Under the Parity Law

December 15 is Bill of Rights Day, a time to recognize and reflect on the freedoms and protections that people in this country have, for it is critical to know your rights to protect those rights.

Among the mental health community, an important right was established in 2008 with the passing of the Mental Health Parity and Addiction Equity Act (MHPAEA). This law made it clear that insurers cannot discriminate against patients with a mental illness, including a substance use disorder.

However, the MHPAEA can be truly effective only if it is properly enforced, and to that end, APA created a poster to help educate patients about mental health parity and their rights under the MHPAEA.

Titled “Fair Insurance Coverage: It’s the Law,” this poster clearly and simply explains the 10 key elements of the law and the steps to take when a violation is suspected.

APA hopes its members and partners join in the effort to protect mental health patients and ensure that all insurers play by the rules. Physicians and therapists should print a copy and post it their office or waiting room, and any other interested parties are likewise encouraged to display the poster in their workplace and/or share the link. Patients and members of the public are invited to download and review the poster as well. Subscribers of Psychiatric News will find a color copy of the poster in the December 5 print edition of the paper.

Learn more about the MHPAEA and find resources related to the law here.

To read APA President Paul Summergrad’s column on this subject, see the Psychiatric News article “Parity Enforcement: A Top Priority.”

(Image: Michelle Holland)

Friday, December 12, 2014

FDA Warns That Ziprasidone May Lead to Potentially Fatal Skin Reaction

Yesterday the Food and Drug Administration (FDA) released a warning stating that the use of ziprasidone (marketed as Geodon), intended to treat schizophrenia and bipolar disorder, may increase risk for a rare but serious skin reaction that can result in death.

The skin reaction, known as drug reaction with eosinophilia and systemic syndromes (DRESS), may start as a rash that can eventually spread to all parts of body. The condition causes a higher-than-normal number of eosinophils, which can lead to fever, swollen lymph nodes, and inflammation of organs such as the heart, kidney, liver, lungs, and pancreas.

The FDA released the warning statement after the agency reviewed information from six patients in whom the symptoms of DRESS appeared between 11 and 30 days after initiating treatment with ziprasidone. Based on this information, the FDA is requiring Pfizer, the drug's manufacturer, to add a new warning for DRESS to the Warning and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.

The FDA is urging health care professionals to stop patient treatment with ziprasidone if DRESS is suspected. They are also asking physicians, as well as patients, to report any side effects involving ziprasidone in the “Contact Information For Voluntary Adverse Event Reporting” section of the FDA MedWatch website.

Thursday, December 11, 2014

APA Urges Senate to Pass Veterans Mental Health Care Bill

APA today joins veterans’ service organizations like the Iraq/Afghanistan Veterans of America, Vietnam Veterans of America, the Wounded Warrior Project, and the Disabled American Veterans in urging the U.S. Senate to pass its version of the Clay Hunt Suicide Prevention for American Veterans (SAV) Act (S. 2930) before adjourning for the year.

The House of Representatives on Tuesday passed a related bill that, among other provisions, encourages increased recruitment of psychiatrists into the Veterans Health Administration through use of a medical school loan repayment program.

APA members can contact their senators by clicking here.

Should the Senate adjourn in the next few days without acting on the measure, the bill will have to be reintroduced in January.

“Many of the nation’s veterans face significant mental health conditions, which are the invisible wounds of war,” said APA President Paul Summergrad, M.D. “Far too often they are not receiving expert, timely care. This legislation is a critical step in helping veterans get the care they need, which is our sacred obligation to provide.”

For more in Psychiatric News about incentives for psychiatrists in the Veterans Health Administration, see: "Psychiatrists’ Pay to Rise at Veterans Health Administration."


Wednesday, December 10, 2014

Mortality Associated With Antipsychotic Dosage Reveals U-Shaped Curve, Study Shows

Among patients with schizophrenia, the cumulative antipsychotic exposure displays a U-shaped curve for overall mortality, revealing the highest risk of death among those patients with no antipsychotic use and those with the highest antipsychotic use. That's the finding of a report on mortality associated with antipsychotic use appearing online in Schizophrenia Bulletin.

It has been generally believed that long-term use of antipsychotics increases mortality and, especially, the risk of cardiovascular death, but no solid data existed to substantiate this. So Swedish researchers identified all individuals in Sweden with schizophrenia diagnoses before year 2006 (N=21,492), aged 17–65 years, and individuals with first-episode schizophrenia during the follow-up, 2006–2010 (N=1,230). Patient information was prospectively collected through nationwide registers. Total and cause-specific mortalities were calculated as a function of cumulative antipsychotic exposure from January 2006 to December 2010.

They found that the highest excess overall mortality was observed among first-episode patients with no antipsychotic use compared with age- and gender-matched controls from the general population. This was followed by patients with high exposure to antipsychotic medication (greater than 1.5 DDD/day). Patients with low exposure (<0.5 DDD/day) and moderate exposure (0.5–1.5 DDD/day) had lower overall mortality. The high exposure and no exposure patients were associated with higher cardiovascular mortality than either low exposure or moderate exposure.

“These results indicate that both excess overall and cardiovascular mortality in schizophrenia is attributable to factors other than antipsychotic treatment when used in adequate dosages,” the researchers state.

For more information, see the Psychiatric News article, "Antipsychotics for Elderly Vary in Mortality Risk."

(Image: Shutterstock)

Tuesday, December 9, 2014

Legislation Would Reduce Number of People With Mental Illness in Jails

"Something is wrong when we use the criminal justice system as a mental health system,” said Sen. Al Franken (D-Minn., left) today at a Capitol Hill briefing. America’s county governments couldn’t agree more.

“Counties across the nation routinely provide services to the estimated two million people with serious mental illnesses booked into jail each year, and prevalence rates of serious mental illnesses in jails are three to six times higher than for the general population,” said representatives of the National Association of Counties (NACo) and the Justice Center of the Council of State Governments (CSG), which organized the briefing.

“The issue affects every county in the nation,” said Rep. Richard Nugent (R-Fla.), a former sheriff of Hernando County, Fla. Nugent is a sponsor of the Justice and Mental Health Collaboration Act of 2013, intended to reduce the number of persons with mental illness in county jails. Franken (D-Minn.) has introduced similar legislation in the Senate.

The legislation would support crisis intervention training for police and diversion programs for offenders, among other measures.

“We need to make a change,” said Judge Steven Leifman of the 11th Judicial Circuit of Florida in Miami and a member of the American Psychiatric Foundation’s board of directors. To further that change, the Foundation, along with NACo and CSG, will convene a summit of county officials and others in 2015 to discuss and disseminate evidence-based solutions.

“Mental health in the justice system is not a partisan issue,” said Franken, urging grassroots support for the pending legislation, which likely awaits further action after the new Congress convenes in January.

"I don’t always agree with Al Franken, but we do agree on this issue,” said Nugent. “I’m optimistic we’ll get this done. It’s important to the people back home.”
For more in Psychiatric News about persons with mental illness in America's jails, see "Judges, Psychiatrists Confer on Handling Mental Illness in Justice System."
--aml (Image: Aaron Levin)

Monday, December 8, 2014

Seniors With Declining Memory Not Visiting Physicians, Study Suggests

More than half of seniors--55 percent--with dementia had no history of cognitive evaluations, reports a new study in Neurology led by researchers at the University of Michigan.

If these data were applied to the broader population, they suggest that around 1.8 million Americans over the age of 70 with dementia have not seen a physician about their memory problems, giving them no opportunity to receive interventions that may slow down their cognitive decline.

The study evaluated 856 seniors 70 and older, and identified 297 participants who met the criteria for dementia. Of those, only 45 percent had seen a physician about their memory problems. In addition, just 5 percent of seniors with mild memory and cognition problems had been tested by a physician for those issues, while 1 percent of seniors with normal memory had undergone cognitive testing.

The researchers tested various clinical and social predictors, and married status was the only demographic that increased the odds of getting a cognitive evaluation; race, income, and proximity of children did not influence cognitive testing.

The study authors said that this research does not answer the question of why seniors aren't seeking help, but suggested that it likely involves a combination of factors involving physicians, patients, and the nature of our health care system. For example, the study data were collected before the initiation of Medicare's free annual wellness exams for seniors, which may improve these discouraging numbers.

To read about how good physical health can keep the mind sharp, see the Psychiatric News article "Cardiovascular Fitness May Help Prevent Early-Onset Dementia."

(shutterstock/Alexander Raths)

Friday, December 5, 2014

FDA to Change Pregnancy and Lactation Labeling Information for Prescription Drugs

On Wednesday, the Food and Drug Administration (FDA) published a final rule that will set new standards for presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15, 2015.

“The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. "The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:

Pregnancy: Containing information such as dosing and potential risks to the developing fetus and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.

Lactation: Containing information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.

Females and Males of Reproductive Potential: Containing information about pregnancy testing, contraception, and infertility as it relates to the drug.

"The new system is potentially more informative and more useful than the old grading system, ... [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines," stated Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. "If the information provided is reasonable and clear, it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions." Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social support therapies—that can safely aid in lessening symptoms of mental illnesses during pregnancy. "If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child," she emphasized.

For research on the use of psychotropic drugs during pregnancy, see the Psychiatric News articles, “Lithium Use in Pregnancy May Contribute to Birth Defects, Miscarriages” and “Certain Cardiac Abnormalities Not Linked to Prenatal Antidepressant Use, Study Finds.”


Thursday, December 4, 2014

Some Prescribing Practices for First-Episode Psychosis Not Concordant With Guidelines, Study Shows

Antipsychotic prescribing for nearly 40% of patients with first-episode psychosis was not concordant with practice guidelines, according to a report, “Prescription Practices in the Treatment of First-Episode Schizophrenia Spectrum Disorders: Data From the National RAISE-ETP Study,” published today in AJP in Advance.

Delbert Robinson, M.D., of Hofstra North Shore-LIJ School of Medicine and colleagues found prescribing patterns were outside guidelines for 159 of 404 first-episode patients at community treatment centers in 21 states. The most common practices that were not concordant with guidelines were use of more than one antipsychotic drug, a higher-than-recommended antipsychotic dosage, using a psychotropic medication other than an antipsychotic, using an antidepressant without justification, and/or use of olanzapine, an antipsychotic that is especially likely to cause significant weight gain but was often prescribed at high dosages nonetheless.

“Although each questionable medication practice we identified affected only 1.2% to 4.4% of patients, cumulatively 39.4% of patients might have benefited from changes in their psychotropic medication prescriptions,” Robinson and colleagues said. “Primary immediate targets for improving first-episode community treatment include discouraging the use of two or more antipsychotics and the prescription of olanzapine, especially at high dosages.”

But many studies have shown that aggressive treatment of first-episode psychosis is crucial to long-term trajectory of illness and outcome, and American Journal of Psychiatry Editor Robert Freedman, M.D., (pictured above) pointed out that some of the prescribing practices identified in the study may not necessarily be clinically inappropriate.

"The prescription acutely of higher doses of antipsychotics, and specifically olanzapine, to first-episode patients is outside guidelines, but whether or not it is misinformed clinical practice has yet to be determined,” he told Psychiatric News. “First-episode patients are often identified by their families and clinicians because they have suddenly become acutely psychotic, and it is often necessary, for both clinical and financial reasons, to decrease their symptoms as quickly as possible." He added that future analyses of the data "may help clarify the reason for these prescription strategies and their utility and thus will ultimately inform guidelines."

For more on this subject, see the Psychiatric News article, "Maryland Undertakes Ambitious Effort at Early ID of Psychosis."

Wednesday, December 3, 2014

Psychosocial Interventions Reduce Risk of Suicidality, Study Finds

A course of eight to 10 sessions of psychotherapy following an incident of deliberate self-harm can help reduce the risk of another such episode, general mortality, and—over the long run—death by suicide, according to research reported by Annette Erlangsen, Ph.D., of the University of Copenhagen, and colleagues online November 24 in the Lancet. The study matched nearly 5,700 people who reported deliberate self-harm and who received psychosocial therapy at suicide-prevention clinics with 17,000 people who did get such therapy. Patients were not randomized to one of the treatment types, and varying types of treatment were used.

In the first year of follow-up, 6.7% of those receiving the psychotherapy intervention recorded another episode of self-harm, compared with 9% of those who did not get therapy. All-cause mortality was also lower in the former group, but rates of completed suicide were not significantly different.

Over a 20-year follow-up, the odds ratio for death by suicide was 0.75 and for death by any cause was 0.69. Younger people, those aged 10 to 24, benefited more than older ones from the psychotherapy intervention. Results were driven mainly by the outcomes among female patients, while outcome differences in male participants were not statistically significant.

“Based on the calculated numbers needed to treat, as many as 145 repeated self-harm episodes and 153 deaths, 30 by suicide, might have been prevented by the psychosocial therapy intervention...,” the researchers concluded.

To read more about research on suicide prevention, see the Psychiatric News article “Big Trial Tests Suicidality and Prevention in Real World.” Also see The American Psychiatric Publishing Textbook of Suicide Assessment and Management, Second Edition.

(aml; Image: WaveBreakMedia/Shutterstock)

Tuesday, December 2, 2014

Act Now to Improve Psychiatric Care for Veterans!

Veterans returning from the wars in Iraq and Afghanistan have an enormous need for mental health care, particularly for treatment of posttraumatic stress disorder (PTSD), substance use disorders, and suicidal thoughts and behaviors. The Veterans Health Administration (VHA) has struggled, however, with mixed degrees of success, to address the needs of the veterans. But legislation before both the Senate and House of Representatives to ameliorate a shortage of VHA psychiatrists could result in significant strides toward helping the agency deliver quality mental health care to veterans.

APA is strongly urging psychiatrists to contact their senators and representatives to register their support for passage of the bill, which is known as the Clay Hunt Suicide Prevention for American Veterans (SAV) Act. The SAV Act (S. 2930/H.R. 5059) would, among other provisions, establish a medical school loan repayment program for psychiatrists in the VHA, which the law's supporters hope will be an effective tool to recruit more psychiatrists to the agency. With Congress considering comprehensive reform to the VHA, there is momentum for improving mental health care, but members of Congress need to hear from their constituents. Click here to contact your representatives urging them to support the Clay Hunt SAV Act.

(image: Orhan Cam/Shutterstock)

Monday, December 1, 2014

Smoking Poses Greater Mortality Risk Than Virus in HIV-Infected People

A recent multinational study shows that among HIV-infected individuals receiving treatment, smoking poses a greater burden on mortality than the virus, which showcases the great progress that has been made in treating a disease once viewed as a death sentence. It also highlights the need to look beyond reducing viral loads and providing comprehensive care to those living with HIV.

The study, which followed nearly 18,000 HIV-infected people on retroviral therapy from North America and Western Europe, found that for a typical 35-year-old man with HIV, smoking reduced life expectancy by about eight years, compared with a six-year reduction directly caused by the virus.

The prevalence of current or former smokers in this study group was around 60%, highlighting a population in which smoking-cessation interventions should be a priority, as it can decrease a tremendous looming health care burden as the HIV-infected population ages. In fact, the study showed that HIV-infected people who never smoked and had good white cell counts had a life expectancy that was virtually identical to that of the general population.

“It is important not to lose sight of the mental health aspects of the disease,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., noting that depression, memory problems, and substance use are all risks among the HIV community. He pledged that APA's Office of HIV Psychiatry will continue to lead efforts in research, education, and outreach about the many aspects of living with HIV.

The lifespan statistics echo those of a newly-released CDC report showing that someone diagnosed with HIV at age 20 has a life expectancy of 71 years with current medications, showing that HIV/AIDS does not preclude someone from living a long and full life—if they take prescribed medicines, adhere to care, and receive supportive services such as proper nutrition, housing, and mental health services.

“We have come a long way in a little over three decades, but continuing efforts at prevention and care—physical, psychological, and social—must be sustained, especially with communities in which there is a high risk of people becoming infected with HIV,” said Marshall Forstein, M.D., an associate professor of psychiatry at Harvard Medical School and a former chair of APA’s Commission on AIDS.

To read about the importance of integrating HIV testing and care in mental health facilities, see the Psychiatric News article, "HIV in Mental Health Facilities Sometimes Gets too Little Attention." Also, watch for the December 5 issue of Psychiatric News, which features additional articles related to HIV and mental health.


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