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

Abstract

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.

• Authors: Lesley M Arnold, Susan L McElroy, James I Hudson, Jeffrey A Welge, Aurora J Bennett, Paul E Keck
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 63 Issue 11 Pg. 1028-33 (Nov 2002) ISSN: 0160-6689 [Print] United States
• PMID: 12444817 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Serotonin Uptake Inhibitors
• Fluoxetine

Topics

• Adult
• Body Mass Index
• Body Weight (drug effects)
• Bulimia (diagnosis, drug therapy, psychology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Feeding Behavior (drug effects)
• Female
• Fluoxetine (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Selective Serotonin Reuptake Inhibitors (administration & dosage, adverse effects)
• Treatment Outcome