Topiramate for Binge Eating Disorder Among Adolescents

Eating Disorders Clinical Trial

Official title:

Open-Label Study of Topiramate for Binge Eating Disorder and Bulimia Nervosa Among Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768677
• Other study ID #: 03-04-063
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: October 7, 2008
• Start date: July 2003

Study information

• Verified date: September 2008
• Source: The Zucker Hillside Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a study of topiramate to see whether topiramate decreases binge eating behavior among adolescents and young adults. The investigators did also checked whether topiramate affected cognitive function or not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 23 Years

Eligibility

Inclusion Criteria:

Subjects (aged 12 to 23) were included if they

• Met the criteria of bulimia nervosa or eating disorder NOS with binge-eating behavior in DSM-IV-TR,

• Had weight > or = 100th % of expected body weight for their age,

• Engaged in binge eating at least once a week for 9 out of the 12 weeks prior to the study entry, and

• Were judged by a clinician to be stable enough to be treated for their psychiatric condition as an outpatient (i.e, no acute suicidality, hallucination, unstable vital signs or persistently abnormal laboratory results due to eating disorder).

Exclusion Criteria:

• Subjects whose psychotropic medications had been changed within 4 weeks prior to the entry or who had started psychotherapy within 3 months prior to the entry were excluded.

• Subjects were also excluded if they were taking carbonic anhydrase inhibitors, carbamazepine, phenytoin, phenobarbital, valproic acid, evening primrose oil or oral contraceptives.

• Other exclusion criteria were: history of substance use disorders within the 6 months prior to study, IQ < or = 70, medical conditions causing weight loss (i.e., hyperthyroidism, diabetes mellitus type 1, malignancy) or that contra indicate treatment with topiramate (nephrolithiasis or glaucoma), history of non response or poor tolerance to topiramate in the past and history of non-adherence to medication treatment.

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Drug:
• topiramate

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Zucker Hillside Hospital

Country where clinical trial is conducted

United States,