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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.

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Women's Health Research Program, Department of Psychiatry, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.



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.

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