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

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.