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Topiramate for Binge Eating Disorder Among Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768677
First Posted: October 8, 2008
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Zucker Hillside Hospital
  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:


Further study details as provided by The Zucker Hillside Hospital:

Study Start Date: July 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768677


Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
The Zucker Hillside Hospital
  More Information

Responsible Party: Ema Saito, The Zucker Hillside Hospital
ClinicalTrials.gov Identifier: NCT00768677     History of Changes
Other Study ID Numbers: 03-04-063
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: October 8, 2008
Last Verified: September 2008

Keywords provided by The Zucker Hillside Hospital:
binge eating behavior
adolescents

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents