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Jonathan R. T. Davidson, MD; Barbara O. Rothbaum, PhD; Bessel A. van der Kolk, MD; Carolyn R. Sikes, PhD; Gail M. Farfel, PhD

Arch Gen Psychiatry. 2001;58:485-492.

Background  Posttraumatic stress disorder (PTSD) is a common illness associated with significant disability. Few large, placebo-controlled trials have been reported.

Methods  Outpatients with a DSM-III-R diagnosis of moderate-to-severe PTSD were randomized to 12 weeks of double-blind treatment with either sertraline (N = 100) in flexible daily doses in the range of 50 to 200 mg or placebo (N = 108). Primary outcome measures consisted of the Clinician-Administered PTSD Scale (CAPS-2) total severity score, the patient-rated Impact of Event Scale (IES), and the Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I) ratings.

Results  Mixed-effects analyses found significantly steeper improvement slopes for sertraline compared with placebo on the CAPS-2 (t = 2.96, P = .003), the IES (t = 2.26, P = .02), the CGI-I score (t = 3.62, P<.001), and the CGI-S score (t = 4.40, P<.001). An intent-to-treat end-point analysis found a 60% responder rate for sertraline and a 38% responder rate for placebo (²₁ = 8.48, P = .004). Sertraline treatment was well tolerated, with a 9% discontinuation rate because of adverse events, compared with 5% for placebo. Adverse events that were significantly more common in subjects given sertraline compared with placebo consisted of insomnia (35% vs 22%), diarrhea (28% vs 11%), nausea (23% vs 11%), fatigue (13% vs 5%), and decreased appetite (12% vs 1%).

Conclusion  The results of the current study suggest that sertraline is a safe, well-tolerated, and significantly effective treatment for PTSD.

From the Anxiety and Traumatic Stress Program, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC (Dr Davidson); the Emory Clinic and Department of Psychiatry and Behavioral Sciences, Atlanta, Ga (Dr Rothbaum); the Human Resource Institute, Brookline, Mass (Dr van der Kolk); and Pfizer Inc, New York, NY (Drs Sikes and Farfel).

Corresponding author and reprints: Jonathan R.T. Davidson, MD, Department of Psychiatry and Behavioral Sciences, Anxiety and Traumatic Stress Program, Duke University Medical Center, Box 3812, Durham, NC 27710.