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.