Fluoxetine in post-traumatic stress disorder. Randomised, double-blind study

Br J Psychiatry. 1999 Jul;175:17-22. doi: 10.1192/bjp.175.1.17.

Abstract

Background: Most pharmacotherapy trials in post-traumatic stress disorder (PTSD) have been conducted upon male combat veterans. Outcome studies relating to civilians are therefore needed.

Aims: To demonstrate that fluoxetine is more effective than placebo in treating PTSD.

Method: Civilians with PTSD (n = 53) were treated for 12 weeks with fluoxetine (up to 60 mg/day) or placebo. Assessments of PTSD severity, disability, stress vulnerability, and high end-state function were obtained.

Results: Fluoxetine was more effective than placebo on most measures at week 12, including global improvement (much or very much improved: fluoxetine 85%, placebo 62%, difference 0.24, 95% CI 0.01-0.47; very much improved: fluoxetine 59%, placebo 19%, difference 0.40, 95% CI 0.16-0.64), and high end-state function (fluoxetine 41%, placebo 4%, difference 0.37, 95% CI 0.17-0.57).

Conclusions: Fluoxetine was superior for measures of PTSD severity, disability, stress vulnerability, and high end-state function. The placebo-group response was low when viewed as a broad outcome based on a portfolio of ratings, but was higher with a traditional global rating criterion.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluoxetine / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Stress Disorders, Post-Traumatic / drug therapy*
  • Treatment Outcome

Substances

  • Antidepressive Agents, Second-Generation
  • Fluoxetine