OBJECTIVE: The authors' goal was to assess the efficacy of sertraline in the treatment of binge eating disorder. METHOD: Thirty-four outpatients with DSM-IV binge eating disorder were randomly assigned to receive either sertraline (N=18) or placebo (N=16) in a 6-week, double-blind, flexible-dose (50-200 mg) study. Except for response level, outcome measures were analyzed by random regression methods, with treatment-by-time interaction as the effect measure. RESULTS: Compared with placebo, sertraline was associated with a significantly greater rate of reduction in the frequency of binges, clinical global severity, and body mass index as well as a significantly greater rate of increase in clinical global improvement. Patients receiving sertraline who completed the study demonstrated a higher level of response, although the effect was not significant. CONCLUSIONS: In a 6-week trial, sertraline was effective and well tolerated in the treatment of binge eating disorder.