Topiramate for Binge Eating Disorder Among Adolescents
This study has been completed.
Sponsor:
The Zucker Hillside Hospital
Information provided by:
The Zucker Hillside Hospital
ClinicalTrials.gov Identifier:
NCT00768677
First received: October 7, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Eating Disorders Bulimia Nervosa |
Drug: topiramate |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | Open-Label Study of Topiramate for Binge Eating Disorder and Bulimia Nervosa Among Adolescents |
Resource links provided by NLM:
MedlinePlus related topics:
Eating Disorders
Drug Information available for:
Topiramate
U.S. FDA Resources
Further study details as provided by The Zucker Hillside Hospital:
Eligibility| Ages Eligible for Study: | 12 Years to 23 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ema Saito, The Zucker Hillside Hospital |
| ClinicalTrials.gov Identifier: | NCT00768677 History of Changes |
| Other Study ID Numbers: | 03-04-063 |
| Study First Received: | October 7, 2008 |
| Last Updated: | October 7, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Zucker Hillside Hospital:
|
binge eating behavior adolescents |
Additional relevant MeSH terms:
|
Bulimia Binge-Eating Disorder Eating Disorders Bulimia Nervosa Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders Topiramate |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 16, 2013