A placebo-controlled, randomized trial of fluoxetine in the treatment of binge-eating disorder

J Clin Psychiatry. 2002 Nov;63(11):1028-33. doi: 10.4088/jcp.v63n1113.


Background: The purpose of this study was to assess the efficacy and safety of fluoxetine in the treatment of binge-eating disorder.

Method: Sixty outpatients with a DSM-IV diagnosis of binge-eating disorder were randomly assigned to receive either fluoxetine, 20 to 80 mg/day (N = 30), or placebo (N = 30) in a 6-week, double-blind, flexible-dose study. The primary measure of efficacy was frequency of binge eating. Secondary measures included body mass index, weight, Clinical Global Impressions-Severity of Illness score, Hamilton Rating Scale for Depression (HAM-D) score, and response categories. The outcome measures were analyzed using 2 random regression methods, a time trend analysis (primary analysis) and an endpoint analysis. In addition, response categories were analyzed using an exact trend test.

Results: Compared with placebo-treated subjects, subjects receiving fluoxetine (mean +/- SD endpoint dose = 71.3 +/- 11.4 mg/day) had a significantly greater reduction in frequency of binge eating (p =.033), body mass index (p <.0001), weight (p =.001), and severity of illness (p =.032) and a marginally significant reduction in HAM-D scores (p =.061). Differences between groups on response categories were not statistically significant.

Conclusion: In a 6-week, placebo-controlled, flexible-dose trial, fluoxetine was efficacious in reducing binge-eating frequency, weight, and severity of illness and was generally well tolerated in subjects with binge-eating disorder.

Publication types

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

MeSH terms

  • Adult
  • Body Mass Index
  • Body Weight / drug effects
  • Bulimia / diagnosis
  • Bulimia / drug therapy*
  • Bulimia / psychology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Feeding Behavior / drug effects
  • Female
  • Fluoxetine / administration & dosage*
  • Fluoxetine / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Selective Serotonin Reuptake Inhibitors / administration & dosage*
  • Selective Serotonin Reuptake Inhibitors / adverse effects
  • Treatment Outcome


  • Serotonin Uptake Inhibitors
  • Fluoxetine