Treatment of Binge Eating in Obese Patients in Primary Care
Overview
- Phase
- Phase 4
- Intervention
- Sibutramine
- Conditions
- Obesity
- Sponsor
- Yale University
- Enrollment
- 104
- Locations
- 3
- Primary Endpoint
- BMI
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.
Investigators
Carlos Grilo
Professor of Psychiatry
Yale University
Eligibility Criteria
Inclusion Criteria
- •Obese (BMI \>= 30)
Exclusion Criteria
- •Medication regimen that represents medical contraindication to sibutramine
- •Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- •Pregnancy
Arms & Interventions
Sibutramine
Sibutramine 15 mg daily
Intervention: Sibutramine
Placebo
Placebo Daily
Intervention: Placebo
Placebo/CBTsh
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Intervention: Self-help CBT + Sibutramine
Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Intervention: Self-help CBT + Placebo
Outcomes
Primary Outcomes
BMI
Time Frame: 4 months
BMI (kg/m\^2) was measured 4 months after treatment.
Binge Eating (Remission)
Time Frame: 4 months treatment; 6 and 12 month follow up post treatment
Remission from binge eating (zero binge episodes during previous 28 days)