Zonisamide in the Treatment of Binge Eating Disorder With Obesity: A Randomized Controlled Trial
J Clin Psychiatry 2006;67(12):1897-1906
© Copyright 2016 Physicians Postgraduate Press, Inc.
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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
zonisamide in the treatment of BED associated with obesity.
Method: 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).
Conclusion: Zonisamide was efficacious,
but not well tolerated, in the short-term treatment
of BED associated with obesity.
Registration: ClinicalTrials.gov identifier NCT00221442