Binge Eating Disorder Associated With Obesity Clinical Trial
Official title:
Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity: A Single Center, Double-Blind, Placebo-controlled, Flexible-Dose Study in Outpatients
The specific aim of this study is to examine the efficacy and safety of zonisamide compared with placebo in outpatients with binge eating disorder associated with obesity.
Binge eating disorder (BED) is characterized by recurrent, uncontrollable, and distressing
episodes of excessive food consumption (binge eating) without compensatory weight loss
behaviors.1,2 Its prevalence in the general population of the United States is
conservatively estimated to be 1.5% to 2%,1-6 making it more common than anorexia nervosa
and bulimia nervosa combined. BED is associated with being overweight and obesity.1-7
Approximately 8% to 30% of those seeking standard weight loss treatments, 1-4 up to 50% of
those seeking bariatric surgery,8,9 and 70% of those participating in Overeaters Annonymous3
are estimated to have BED.
Zonisamide is a structurally and pharmacologically novel antiepileptic drug - a
sulfamate-substituted monosaccharide - with proven anticonvulsant efficacy when used
adjunctively in refractory partial epilepsy.10-12 Mechanisms hypothesized to account for
zonisamide's antiepileptic properties include antagonism of voltage-gated sodium and T-type
calcium channels, blockade of potassium-evoked glutamate release, modulation of central
dopaminergic and serotonergic function, and carbonic anhydrase inhibition.10-16 Several
lines of evidence suggest that zonisamide might be a useful treatment for BED. First, like
the anticonvulsant topiramate,17-19 zonisamide has been associated with anorexia and weight
loss in clinical trials in epilepsy patients10,11,20 and in patients with obesity.20
Topiramate has also been shown to reduce binge eating and weight in patients with binge
eating disorder associated with obesity. 21 Although zonisamide and topiramate have distinct
pharmacologic profiles, both drugs share several pharmacologic actions. These include sodium
channel blockade, carbonic anhydrase inhibition, and reduction of glutamate
neurotransmission. 10,11,13,16,17 Regarding the latter property, animal studies have shown
that stimulation of the lateral hypothalamus by glutamate and glutamate agonists causes an
intense, rapid, dose-dependent increase in food intake,22 whereas glutamate antagonism of
the nucleus tractus solitarius reduces food intake.23 Second, unlike topiramate, zonisamide
also modulates the function of serotonin and dopamine14, 15 --two neurotransmitters involved
in the regulation of feeding behavior24 and the mechanisms of some medications with efficacy
in either binge eating (SSRIs, d-fenfluramine) 25-29 or obesity (sibutramine, stimulants).30
Third, a broad range of antidepressants have been reported to reduce binge eating in both
bulimia nervosa31 and binge eating disorder25-28,32 and preliminary observations suggest
zonisamide may have thymoleptic properties.33,34 Fourth, in an open-label trial of
zonisamide in 15 patients with BED conducted by our group, zonisamide was effective in
reducing binge eating frequency, severity of illness, and weight (S.L. McElroy, J Clin
Psychiatry, under review).35 We therefore propose to conduct a double-blind,
placebo-controlled, randomized, parallel group, 16-week study of zonisamide in 60
outpatients with binge eating disorder and obesity.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06230107 -
The Effects of Nutritional Intervention in Participants With Eating Disorders.
|
N/A |