Zonisamide in the treatment of binge eating disorder with obesity: a randomized controlled trial.
OBJECTIVE
Binge eating disorder (BED) is associated with obesity. Zonisamide is a novel antiepileptic drug associated with weight loss. The purpose of this study was to evaluate zonisa-mide in the treatment of BED associated with obesity.


METHODS
In this 16-week, single-center, randomized, double-blind, placebo-controlled, flexible-dose (100-600 mg/day) trial, 60 outpatients with DSM-IV-TR BED received zonisamide (N = 30) or placebo (N = 30). The primary outcome measure was weekly frequency of binge eating episodes. 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 5, 2003, through October 1, 2004.


RESULTS
Compared with placebo, zonisamide was associated with a significantly greater rate of reduction in binge eating episode frequency (p = .021), body weight (p < .001), BMI (p = .001), and scores on the Clinical Global Impressions-Severity scale (p < .001), Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (p < .001), and Three Factor Eating Questionnaire disinhibition scales (p < .001). Plasma ghrelin concentrations increased with zonisamide but decreased with placebo (p = .001). The mean (SD) zonisamide daily dose at endpoint evaluation was 436 (159) mg/day. Twelve patients (N = 8 receiving zonisamide, N = 4 receiving placebo) discontinued because of adverse events. The most common reasons for discontinuing zonisamide were accidental injury with bone fracture (N = 2), psychological complaints (N = 2), and cognitive complaints (N = 2).


CONCLUSIONS
Zonisamide was efficacious, but not well tolerated, in the short-term treatment of BED associated with obesity.


BACKGROUND
ClinicalTrials.gov identifier NCT00221442.
McElroy
Susan L
SL
Psychopharmacology Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, OH 45267-0559, USA. susan.mcelroy@uc.edu
Kotwal
Renu
R
Guerdjikova
Anna I
AI
Welge
Jeffrey A
JA
Nelson
Erik B
EB
Lake
Kathleen A
KA
D'Alessio
David A
DA
Keck
Paul E
PE
Hudson
James I
JI
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D002032:Bulimia / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000523:psychology; D015431:Weight Loss; D000078305:Zonisamide
D000927:Anticonvulsants; D007555:Isoxazoles; D000078305:Zonisamide