Phase 4
N=104
Treatment of Binge Eating in Obese Patients in Primary Care
Obesity · Binge Eating
Bottom Line
View on ClinicalTrials.gov: NCT00537810 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Binge Eating (Remission) — 10; 8; 6; 6 participants — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sibutramine (Drug); Placebo (Drug); Self-help CBT + Sibutramine (Behavioral); Self-help CBT + Placebo (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Eating (Remission) |
10; 8; 6; 6; 5; 11 | 0.60 |
| PRIMARY BMI |
38.4; 39.6; 35.9; 35.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00537810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.