Military Announces Clinical Trials Set For PTSD Drugs

PTSDOur country has been at war for over a decade.  Our soldiers are tired and weary, and many dealing with severe issues, such as Post Traumatic Stress Disorder (PTSD) from the things they have seen and experienced on the battlefield.

Although doctors like Dr. Elspeth Cameron Ritchie whom recently retired from the U.S. Army as a colonel and is now the chief clinical officer for the District of Columbia’s department of mental health, encourages counseling in several forms and consideration for such things as acupuncture, yoga and therapy dogs to help veterans adjust, many military and Veterans Affairs Department physicians often prescribe medication to ease the symptoms of combat-related PTSD.

But, there are only two antidepressantsPaxil and Zoloft — that are approved specifically by the Food and Drug Administration to treat the disorder.  And, little data exists on which “off-label” medications work and which don’t.

Therefore, according to recent announcements, the Army is trying to get a better handle on the very complicated issue of how drugs fit into the treatment of these traumatized veterans, with a study of the effectiveness of the drugs most often prescribed. The research will be launched next year, reports The Navy Times.

Speaking at the American Psychiatric Association meeting in Philadelphia, Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences announced the service will start clinical trials next year to evaluate commonly prescribed PTSD medications like the antidepressant Cymbalta, mirtazapine, prazosin and atypical antipsychotics like Seroquel. It will test hundreds of vets and service members at multiple sites over several years.

“We’re trying to advance the science to catch up with clinical practice,” Wynn said. “This effort will seek to provide clinicians with a higher level of evidence when choosing a drug.” says Army Major Wynn.

The announcement follows a memo on February 22 from Assistant Secretary of Defense Jonathan Woodson to all of the branches of the military about what the military was seeing in PTSD treatment, expressing that “the greatest concern is the suspicion of the over-prescription of antipsychotic medications for PTSD.”

In it, he also points out that while antidepressant use had changed little between 2002 and 2009, the prescription rates for atypical antipsychotics increased by 10 times during that period, from 0.1% to 1%. The memo says AstraZeneca’s Seroquel was prescribed to 1.4% of the Army and 0.7% of the Marines in fiscal year 2010.

On April 10, the Army’s Office of the Surgeon General also issued a guidance memo for PTSD, including caution about antipsychotic drugs. “There are numerous concerns with potential long-term adverse health effects,” the memo said, “and these medications have shown disappointing results in clinical trials in the treatment of PTSD.”

Wynn and Benedik hope their efforts will lead to better treatments for PTSD in both combat veterans and civilians.

“For pharmaceuticals that show benefits in treating combat-related PTSD, the Department of Defense may work toward a new indication or change in labeling,” Wynn said.

Published results from the first trial are expected by 2016.

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