Failed efficacy of fluoxetine in the treatment of posttraumatic stress disorder: results of a fixed-dose, placebo-controlled study

J Clin Psychopharmacol. 2007 Apr;27(2):166-70. doi: 10.1097/JCP.0b013e31803308ce.

Abstract

A multicenter, double-blind, 12-week, placebo-controlled trial of 411 randomized patients, predominantly women diagnosed with posttraumatic stress disorder, failed to show a difference between either dose of fluoxetine treatment and placebo. The mean changes from baseline (SD) measured by the Clinician-Administered PTSD Scale scores were -42.9 (23.1), -42.8 (27.9), and -36.6 (25.7) in the 20-mg fluoxetine, 40-mg fluoxetine, and placebo arms, respectively. Placebo response rate was substantially higher in this study than in a previously published fluoxetine trial of posttraumatic stress disorder.

Publication types

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

MeSH terms

  • Adult
  • Antidepressive Agents, Second-Generation / administration & dosage
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / therapeutic use
  • Diagnostic and Statistical Manual of Mental Disorders
  • Disorders of Excessive Somnolence / chemically induced
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fluoxetine / administration & dosage
  • Fluoxetine / adverse effects
  • Fluoxetine / therapeutic use*
  • Headache / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Patient Dropouts / statistics & numerical data
  • Psychiatric Status Rating Scales
  • Psychometrics / methods
  • Stress Disorders, Post-Traumatic / drug therapy*
  • Stress Disorders, Post-Traumatic / psychology
  • Time Factors
  • Treatment Failure
  • Withholding Treatment / statistics & numerical data

Substances

  • Antidepressive Agents, Second-Generation
  • Fluoxetine