Fluvoxamine in the treatment of binge-eating disorder: A multicenter placebo-controlled, double-blind trial

Objective: The purpose of this study was to assess the efficacy of fluvoxam ine in the treatment of binge-eating disorder. Binge-eating disorder is a n ewly described eating disorder characterized by recurrent episodes of binge eating but without purging behaviors. Uncontrolled reports have suggested that serotonin selective reuptake inhibitors (SSRIs) may be effective in tr eating this disorder. Method: Eighty-five outpatients with a DSM-IV diagnos is of binge-eating disorder were randomly assigned to receive either fluvox amine (N=42) or placebo (N=43) in a 9-week, parallel-group, double-blind, f lexible dose (50-300 mg) study at three centers. The primary outcome measur es were frequency of binge eating, expressed as log ([binges/week]+1), and Clinical Global Impression (CGI) scale ratings. Secondary measures included the level of response (based on the percentage change in frequency of bing es), body mass index, and Hamilton Rating Scale for Depression score. Excep t for the level of response, the outcome measures were analyzed by random r egression methods; the treatment-by-time interaction was the measure of tre atment effect. Results: Compared with placebo, fluvoxamine was associated w ith a significantly greater rate of reduction in the frequency of binges, r ate of reduction in CGI severity scores, rate of increase in CGI improvemen t scores, level of response for patients who completed the 9-week study, an d rate of reduction in body mass index. There was no significant difference between placebo and fluvoxamine groups in the rate of decrease in Hamilton depression scale scores. A significantly greater proportion of patients re ceiving fluvoxamine than those receiving placebo discontinued treatment bec ause of an adverse medical event. Conclusions: In this placebo-controlled t rial, fluvoxamine was found to be effective according to most outcome measu res in the acute treatment of binge-eating disorder.