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

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.

• Authors: J R Davidson, B O Rothbaum, B A van der Kolk, C R Sikes, G M Farfel
• Journal: Archives of general psychiatry (Arch Gen Psychiatry) Vol. 58 Issue 5 Pg. 485-92 (May 2001) ISSN: 0003-990X [Print] United States
• PMID: 11343529 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Serotonin Uptake Inhibitors
• Sertraline

Topics

• 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)
• Selective Serotonin Reuptake Inhibitors (therapeutic use)
• Sertraline (adverse effects, therapeutic use)
• Severity of Illness Index
• Sleep Initiation and Maintenance Disorders (chemically induced)
• Stress Disorders, Post-Traumatic (drug therapy, psychology)
• Treatment Outcome