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Topiramate for Binge Eating Disorder Among Adolescents

Primary Purpose

Eating Disorders, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
topiramate
Sponsored by
The Zucker Hillside Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring binge eating behavior, adolescents

Eligibility Criteria

12 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Zucker Hillside Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 7, 2008
Last Updated
October 7, 2008
Sponsor
The Zucker Hillside Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00768677
Brief Title
Topiramate for Binge Eating Disorder Among Adolescents
Official Title
Open-Label Study of Topiramate for Binge Eating Disorder and Bulimia Nervosa Among Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Zucker Hillside Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Bulimia Nervosa
Keywords
binge eating behavior, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topiramate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

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Topiramate for Binge Eating Disorder Among Adolescents

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