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

Background: Posttraumatic stress disorder (PTSD) is a common illness associ ated 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 sertralin e (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-Administere d PTSD Scale (CAPS-2) total severity score, the patient-rated impact of Eve nt Scale (IES), and the Clinical Global Impression-Severity (CGI-S) and -Im provement (CGI-I) ratings. Results: Mixed-effects analyses found significantly steeper improvement slo pes for sertraline compared with placebo oil the CAPS-2 (t=2.96, P=.003), t he IES (t=2.26, P=.02), the CGI-I score (t=3.62, P<.001), and the CGI-S sco re (t=4.40, P<.001). An intent-to-treat end-point analysis found a 60% resp onder 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% discont inuation rate because of adverse events, compared with 5% for placebo. Adve rse events that a cre significantly more common in subjects given sertralin e compared with placebo consisted of insomnia (35% vs 22%), diarrhea (28% v s 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 s afe, well-tolerated, and significantly effective treatment for PTSD.