NCT00768677

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
Last Updated

October 8, 2008

Status Verified

September 1, 2008

First QC Date

October 7, 2008

Last Update Submit

October 7, 2008

Conditions

Keywords

binge eating behavioradolescents

Interventions

Eligibility Criteria

Age12 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaBinge-Eating Disorder

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

July 1, 2003

Last Updated

October 8, 2008

Record last verified: 2008-09

Locations