Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Obesity
Binge-Eating Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 a...
Detailed Description
Binge-Eating Disorder (BED) is characterized by recurrent binge eating without extreme behaviors to lose weight (e.g., self-induced vomiting, misuse of laxatives) resulting in marked distress, feeling...
Eligibility Criteria
Inclusion
- Diagnosis of binge-eating disorder
- 3 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00210808
Start Date
September 1 2003
End Date
March 1 2005
Last Update
June 10 2011
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