A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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