Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221442
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2005-09-14
Brief Title:
Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity
Sponsor:
Lindner Center of HOPE
Organization:
Lindner Center of HOPE
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Binge eating disorder BED is characterized by recurrent uncontrollable and distressing episodes of excessive food consumption binge eating without compensatory weight loss behaviors12 Its prevalence in the general population of the United States is conservatively estimated to be 15 to 21-6 making it more common than anorexia nervosa and bulimia nervosa combined BED is associated with being overweight and obesity1-7 Approximately 8 to 30 of those seeking standard weight loss treatments 1-4 up to 50 of those seeking bariatric surgery89 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 epilepsy10-12 Mechanisms hypothesized to account for zonisamides 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 inhibition10-16 Several lines of evidence suggest that zonisamide might be a useful treatment for BED First like the anticonvulsant topiramate17-19 zonisamide has been associated with anorexia and weight loss in clinical trials in epilepsy patients101120 and in patients with obesity20 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 1011131617 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 intake22 whereas glutamate antagonism of the nucleus tractus solitarius reduces food intake23 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 stimulants30 Third a broad range of antidepressants have been reported to reduce binge eating in both bulimia nervosa31 and binge eating disorder25-2832 and preliminary observations suggest zonisamide may have thymoleptic properties3334 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 SL McElroy J Clin Psychiatry under review35 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
Zonisamide is a structurally and pharmacologically novel antiepileptic drug - a sulfamate-substituted monosaccharide - with proven anticonvulsant efficacy when used adjunctively in refractory partial epilepsy10-12 Mechanisms hypothesized to account for zonisamides 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 inhibition10-16 Several lines of evidence suggest that zonisamide might be a useful treatment for BED First like the anticonvulsant topiramate17-19 zonisamide has been associated with anorexia and weight loss in clinical trials in epilepsy patients101120 and in patients with obesity20 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 1011131617 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 intake22 whereas glutamate antagonism of the nucleus tractus solitarius reduces food intake23 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 stimulants30 Third a broad range of antidepressants have been reported to reduce binge eating in both bulimia nervosa31 and binge eating disorder25-2832 and preliminary observations suggest zonisamide may have thymoleptic properties3334 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 SL McElroy J Clin Psychiatry under review35 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None