Contact: Ellen Bank


Tuesday, April 11, 2000

Drug Sertraline Effective Treatment for Posttraumatic Stress Disorder

More than half of the patients experienced substantial improvement

CHICAGO - Patients with posttraumatic stress disorder (PTSD) taking sertraline drug treatment reported significant improvement in symptoms and functioning, according to an article in the April 12 issue of The Journal of the American Medical Association (JAMA).

Kathleen Brady, M.D., Ph.D., professor of psychiatry and behavioral sciences at the Medical University of South Carolina, Charleston, and colleagues conducted a placebo-controlled study from May 1996 to June 1997 to examine the efficacy of sertraline (a selective serotonin reuptake inhibitor antidepressant drug) with187 patients from outpatient psychiatric clinics in eight academic medical centers and six clinical research centers. The 12-week study was done to determine if treatment with sertraline effectively diminishes symptoms of PSTD of moderate to marked severity.

The researchers found sertraline to be significantly more effective than placebo (inactive medication) in the treatment of PTSD across a spectrum of illness-specific global and functioning outcome measures. In the efficacy analysis, 53 percent of patients receiving sertraline were much or very much improved at treatment end point, compared to 32 percent of patients receiving placebo, with benefit from sertraline often present within the first four weeks of treatment.

The clinical presence of PTSD is characterized by moderate-to-severe symptoms in three separate domains, including reexperiencing (intrusive thoughts, nightmares, flashbacks, images or memories); emotional numbing and avoidance (flattened affect or avoidance of any activity, place, person or topic associated with the trauma); and increased arousal (startle reactions, poor concentration, irritability and jumpiness, insomnia or hypervigilance).

According to background information in the study, traumatic stress is a significant public health problem that frequently results in a distinctive pattern of persistent and disabling psychological and physiological symptoms. Once thought to be primarily limited to soldiers in combat, PTSD is now recognized in civilians, including those who have experienced natural disasters, physical and sexual assault, fire, motor vehicle and other serious trauma, as well as those who have witnessed inflicted injury or death.

The authors add that "with a minimum symptom duration of one month at a level of severity necessary to impair an individual's functioning, PTSD has been estimated to have a lifetime prevalence in the range of 5 percent to 12 percent, based on epidemiological surveys, with women having twice the prevalence rate of men. Frequently, PTSD is a chronic illness with a median time to recovery in the range of three to five years."

For patients who completed the study, sertraline treatment was also associated with significant improvement in measures of social and occupational functioning, as well as perception of improved quality of life. "A potential therapeutic advantage of sertraline as a treatment for PTSD is its established efficacy in treating disorders commonly comorbid with PTSD, such as depression and panic disorder."

The researchers suggest that "Additional research is needed to determine whether subgroups of PTSD patients might respond preferentially to drug or behavioral treatments or might optimally benefit from combination therapy. Finally what constitutes an adequate therapeutic trial and whether or when patients with PTSD might benefit from long-term treatment are also issues that await further research."

(JAMA. 2000;283:1837-1844).

Editor's Note: The study was funded by Pfizer, Inc. Dr. Brady and co-authors Teri Pearlstein, M.D., Gregory M. Asnis, M.D., Dewleen Baker, M.D., and Barbara Rothbaum, Ph.D., were investigators on additional multisite studies on the efficacy and safety of sertraline in the treatment of posttraumatic stress disorder conducted by Pfizer Inc. Dr. Brady is a member of the Pfizer advisory board and has receive support from Pfizer in the form of honoraria and grant support. Dr. Pearlstein is also a consultant to Pfizer, and Carolyn R. Sikes, Ph.D. and Gail M. Farfel, Ph.D., own stock and have stock options with Pfizer.