Atomoxetine in the treatment of binge-eating disorder: a randomized placebo-controlled trial.
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.


METHODS
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 sub-scale, 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 atomoxe-tine, 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).


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


BACKGROUND
ClinicalTrials.gov identifier NCT00327834.
McElroy
Susan L
SL
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, OH 45267-0559, USA. susan.mcelroy@uc.edu
Guerdjikova
Anna
A
Kotwal
Renu
R
Welge
Jeffrey A
JA
Nelson
Erik B
EB
Lake
Kathleen A
KA
Keck
Paul E
PE
Hudson
James I
JI
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000069445:Atomoxetine Hydrochloride; D015992:Body Mass Index; D001835:Body Weight; D052018:Bulimia Nervosa / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride