A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity
1 other identifier
interventional
407
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in reducing the number of binge days in patients with moderate to severe binge-eating disorder associated with obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Sep 2003
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
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedJune 10, 2011
April 1, 2010
September 13, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of change in the number of binge days per week from baseline at 16 weeks or final visit.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of binge-eating disorder
- or more binge days per week in the 2 weeks prior to baseline
- Obese (body mass index \>=30 and \<=50 kilograms per square meter)
- Uncomplicated/controlled Type II diabetes or hypertension are acceptable
- In generally good health
- If female capable of having children, using acceptable method of birth control
You may not qualify if:
- No current or past history of schizophrenia, other psychotic disorder, or bipolar disorder
- Significant depression that requires treatment with medication or therapy
- At risk to self or others
- No current or recent (within 3 months) diagnosis of abusing drugs or alcohol
- Initiation of formal psychiatric therapy in past 6 months for binge-eating disorder or any other psychiatric disorder
- Pregnant or breast-feeding
- No clinically significant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
McElroy SL, Hudson JI, Capece JA, Beyers K, Fisher AC, Rosenthal NR; Topiramate Binge Eating Disorder Research Group. Topiramate for the treatment of binge eating disorder associated with obesity: a placebo-controlled study. Biol Psychiatry. 2007 May 1;61(9):1039-48. doi: 10.1016/j.biopsych.2006.08.008. Epub 2007 Jan 29.
PMID: 17258690RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
September 1, 2003
Study Completion
March 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-04