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J Clin Psychiatry. 2002 Nov;63(11):1028-33.

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

Author information

  • 1Women's Health Research Program, Department of Psychiatry, University of Cincinnati Medical Center, Cincinnati, Ohio, USA. Lesley.Arnold@uc.edu



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


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.


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.


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.

[PubMed - indexed for MEDLINE]
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