Atomoxetine in the Treatment of Binge-Eating Disorder: A Randomized Placebo-Controlled Trial

Susan L. McElroy, M.D.; Anna Guerdjikova, Ph.D.; Renu Kotwal, M.D.; Jeffrey A. Welge, Ph.D.; Erik B. Nelson, M.D.; Kathleen A. Lake, M.S.W.; Paul E. Keck, Jr., M.D.; and James I. Hudson, M.D., Sc.D.

Objective: Binge-eating disorder (BED) is associated with obesity. Atomoxetine is a highly selective norepinephrine reuptake inhibitor associated with weight loss. The purpose of this study was to evaluate atomoxetine in the treatment of BED.

Method: In this 10-week, single-center, randomized, double-blind, placebo-controlled, flexible dose (40-120 mg/day) trial, outpatients with DSM-IV-TR BED received atomoxetine or placebo. The primary outcome measure was binge-eating episode frequency. The primary analysis of efficacy was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the effect measure. Patients were enrolled from September 2004 through October 2005.

Results: Compared with placebo (N = 20), atomoxetine (N = 20) was associated with a significantly greater rate of reduction in binge-eating episode frequency, as well as in binge day frequency, weight, body mass index, and scores on the Clinical Global Impressions-Severity of Illness scale, Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating obsession subscale, and Three Factor Eating Questionnaire hunger subscale. The mean (SD) atomoxetine daily dose at endpoint evaluation was 106 (21) mg/day. Four patients (N = 3 receiving atomoxetine, N = 1 receiving placebo) discontinued because of adverse events. The reasons for atomoxetine discontinuation were increased depressive symptoms (N = 1), constipation (N = 1), and nervousness (N = 1).

Conclusion: Atomoxetine was efficacious and fairly well tolerated in the short-term treatment of BED.

Clinical Trials Registration: ClinicalTrials.gov identifier NCT00327834.

(J Clin Psychiatry 2007;68:390-398)

Received May 24, 2006; accepted July, 19, 2006. From the Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine (Drs. McElroy, Guerdjikova, Kotwal, Welge, Nelson, and Keck and Ms. Lake), and Mental Health Service Line and General Clinical Research Center, Cincinnati Veterans Affairs Medical Center (Dr. Keck), Cincinnati, Ohio; and the Department of Psychiatry, Harvard Medical School and McLean Hospital, Belmont, Mass. (Dr. Hudson).

This study was supported in part by a grant from Eli Lilly, Indianapolis, Ind.

Individual financial disclosure can be found at the end of this article.

Corresponding author and reprints: Susan L. McElroy, M.D., Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, P.O. Box 670559, 231 Albert Sabin Way, Cincinnati, OH 45267-0559(e-mail: susan.mcelroy@uc.edu).