APA 2012

Seeking to improve outcomes for patients with combat-related Post-Traumatic Stress Disorder (PTSD), the U.S. Army is leading a new research initiative that will examine the efficacy of multiple FDA-approved pharmacotherapeutics.

This multi-year, multi-site series of clinical trials will systematically evaluate a range of pharmaceuticals. The first trial, scheduled to start enrolling patients in 2013, will evaluate the utility of several commonly prescribed drugs currently used off-label to treat PTSD or major PTSD symptom clusters.

“We’re trying to advance the science to catch up with clinical practice,” said Maj. Gary H. Wynn, M.D., research psychiatrist, Center for Military Psychiatry and Neuroscience at the Walter Reed Army Institute of Research. “Much of the current pharmacologic treatment of combat-related PTSD is off-label and, while there are anecdotal information and small trials supporting that usage, this effort will seek to provide clinicians with a higher level of evidence when choosing a drug.”

Maj. Wynn and Col. David M. Benedek, M.D., professor/deputy chair, Department of Psychiatry, and associate director, Center for the Study of Traumatic Stress, at the Uniformed Services University of the Health Sciences, highlighted this new initiative during the Advances in Series 2: Advances in Post- Traumatic Stress Disorder session here in Philadelphia. The effort will involve dozens of military and collaborator medical facilities and hundreds of patients.

The Army has long supported clinicians determining the best treatment plan based on individual patient needs – whether that includes psychotherapy, a medication or both. Yet, the lack of evidence-based guidelines for medication management of PTSD is a key driver for this large-scale effort to study the ability of various pharmaceuticals to ease PTSD symptoms.

“The overall goal will be to provide better guidance to clinicians who treat combat-related PTSD so service members and veterans receive the highest level of care,” said Maj. Wynn. “For pharmaceuticals that show benefits in treating combat-related PTSD, the Department of Defense may work toward a new indication or change in labeling.”

The Army plans to publish results from the first trial in 2016 and share ongoing study findings with the broader behavioral health community at future medical meetings. As appropriate, the Army also will submit findings from this initiative to the Food and Drug Administration to support potential new indications for select, FDA-approved medications.

According to Maj. Wynn, future trials may also include development of novel compounds that show promise in treating combat-related PTSD in order to increase the treatment options at a clinician’s disposal. Ultimately, this initiative may help advance clinical practice guidelines and drive more effective treatment for both military and civilian patients suffering from PTSD.

For Steven E. Hyman, M.D., one of this year’s APA Distinguished Psychiatrist Lecturers, the upcoming publication of DSM-5 is just a beginning. He said he hopes the document, which is due to be published in May 2013, will lead to greater innovation in psychiatric research and practice.

“We need find ways of unshackling science that will encourage scientists to recluster and create a diagnostic system from the bottom up,” said Dr. Hyman, who will discuss how the DSM-5 will affect the future of psychiatric practice and research at 11 a.m. today in Room 115A-C, Level 1, Pennsylvania Convention Center. His lecture is titled “Can We Safely Deliver the DSM-5 Into the 21st Century?”

One of the expected changes in the DSM-5 is the introduction of dimensional diagnoses, such as within the autism spectrum, which has garnered notice in the popular press. “The science tells us most of the disorders we have are not categories,” Dr. Hyman said. “Fundamentally, the DSM-3 had too many individual categories when, in fact, the world is better represented by dimensions and probably larger grouping.”

The DSM-3, published in 1980, is considered a foundation work that led to significant successes in psychiatric research and clinical practice over the last few decades. But it was based on science of the 1960s and 1970s.

“It is not surprising we are discovering substantial problems with its organization,” said Dr. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology. “The core problem that the intellectual forbearers of the DSM-3 couldn’t foresee is the genetic complexity of psychiatric disorders.”

The lack of objective medical tests for the vast majority of disorders listed in the manual led to the creation of operationalized diagnostic criteria. This enhanced interrater reliability and helped psychiatrists agree on diagnoses. But research into the genetic factors of mental disease has made the categorization of mental disorders too simplistic.

“The DSM-3 was a brilliant document that could not have foreseen the science,” Dr. Hyman said. “It’s time to move on scientifically.”

In some ways, the DSM-3 also hindered innovation, Dr. Hyman said. Researchers seeking National Institutes of Health grants or trying to publish in a top journal have to follow DSM criteria. But in some ways, those researchers could never get outside the DSM criteria and look at other ways of classifying psychopathology.

“For example, it was very hard to get a grant to test the hypothesis that maybe the apparent comorbidity of multiple anxiety disorder and mood disorders was just that there was a single underlying process or single disorder that got expressed with different symptom complexes in different times in life, or depending upon different environments or context one lived in,” Dr. Hyman explained.

The Association of Women Psychiatrists (AWP) will honor the late Tana Grady- Weliky, M.D., a past AWP president, during its Women’s Networking & Mentoring Breakfast tomorrow at 7:30 a.m. in Room 501A, Level 5, Philadelphia Marriot Downtown.

“This event was extremely well attended last year and is a wonderful tribute to the memory and work of our esteemed colleague who cared deeply about the continued advancement of women in psychiatry,” said Patricia Isbell Ordorica, M.D., AWP President.

The Association of Women Psychiatrists (AWP) will honor Donna M. Norris, M.D., with the 2012 Jeanne M. Spurlock, M.D. Social Justice Award at the AWP Annual Awards Evening and joint meeting with APA’s Women’s Caucus today at 5:30 p.m. in the Grand Ballroom, Salon A, Level 5, Philadelphia Marriott Downtown.

Dr. Norris is being honored with this award for her extraordinary dedication to and creative leadership efforts in the personal and professional development of women and minorities. Dr. Norris is the editor of the recently published book, “Women in Psychiatry: Personal Perspectives.”