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

Arch Gen Psychiatry. 2001 May;58(5):485-92. doi: 10.1001/archpsyc.58.5.485.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Diarrhea / chemically induced
  • Double-Blind Method
  • Fatigue / chemically induced
  • Feeding and Eating Disorders / chemically induced
  • Female
  • Humans
  • Male
  • Nausea / chemically induced
  • Placebos
  • Psychiatric Status Rating Scales / statistics & numerical data
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Sertraline / adverse effects
  • Sertraline / therapeutic use*
  • Severity of Illness Index
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Stress Disorders, Post-Traumatic / drug therapy*
  • Stress Disorders, Post-Traumatic / psychology
  • Treatment Outcome

Substances

  • Placebos
  • Serotonin Uptake Inhibitors
  • Sertraline