A placebo-controlled, randomized trial of fluoxetine in the treatment of binge-eating disorder
Arnold, L.M.; McElroy, S.L.; Hudson, J.I.; Welge, J.A.; Bennett, A.J.; Keck, P.E.
Journal of Clinical Psychiatry 63(11): 1028-1033
2002
ISSN/ISBN: 0160-6689 PMID: 12444817 Document Number: 545577
Background: The purpose of this study was to assess the efficacy and safety of fluoxetine in the treatment of binge-eating disorder. Method: 60 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 [USA; date not given]. 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 analysed using 2 random regression methods, a time trend analysis (primary analysis) and an endpoint analysis. In addition, response categories were analysed using an exact trend test. Results: Compared with placebo-treated subjects, subjects receiving fluoxetine (mean+or-SD endpoint dose=71.3+or-11.4 mg/day) had a significantly greater reduction in frequency of binge eating (p=0.033), body mass index (p<0.0001), weight (p=0.001), and severity of illness (p=0.032) and a marginally significant reduction in HAM-D scores (p=0.061). 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.