Zonisamide in the treatment of binge eating disorder with obesity: a randomized controlled trial.

Abstract

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.

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.

CLINICAL TRIALS REGISTRATION:

ClinicalTrials.gov identifier NCT00221442.

• Authors: Susan L McElroy, Renu Kotwal, Anna I Guerdjikova, Jeffrey A Welge, Erik B Nelson, Kathleen A Lake, David A D'Alessio, Paul E Keck, James I Hudson
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 67 Issue 12 Pg. 1897-906 (Dec 2006) ISSN: 1555-2101 [Electronic] United States
• PMID: 17194267 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants
• Isoxazoles
• Zonisamide

Topics

• Adult
• Anticonvulsants (adverse effects, therapeutic use)
• Body Mass Index
• Bulimia (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Isoxazoles (adverse effects, therapeutic use)
• Male
• Middle Aged
• Obesity (drug therapy, psychology)
• Weight Loss
• Zonisamide