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

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

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 (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 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.

Full Text

Duke Authors

Cited Authors

  • Davidson, JR; Rothbaum, BO; van der Kolk, BA; Sikes, CR; Farfel, GM

Published Date

  • May 2001

Published In

Volume / Issue

  • 58 / 5

Start / End Page

  • 485 - 492

PubMed ID

  • 11343529

International Standard Serial Number (ISSN)

  • 0003-990X

Digital Object Identifier (DOI)

  • 10.1001/archpsyc.58.5.485


  • eng

Conference Location

  • United States