Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder

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 oil 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 (chi (2)(1) = 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 a cre 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.