Fluoxetine v. placebo in prevention of relapse in post-traumatic stress disorder

Br J Psychiatry. 2002 Oct:181:315-20. doi: 10.1192/bjp.181.4.315.


Background: Little is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse.

Aims: To assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse.

Method: This was a double-blind, randomised, placebo-controlled study. Following 12 weeks of acute treatment, patients who responded were rerandomised and continued in a 24-week relapse prevention phase with fluoxetine (n=69) or placebo (n=62). The primary efficacy assessment was the prevention of PTSD relapse, based on the time to relapse.

Results: Patients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group (P=0.027). There were no clinically significant differences in treatment-emergent adverse events between treatment groups.

Conclusions: Fluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Secondary Prevention
  • Stress Disorders, Post-Traumatic / prevention & control*


  • Antidepressive Agents, Second-Generation
  • Fluoxetine