Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sibutramine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges) | 6 months | |
| Change from baseline in Body Weight | 6 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Bacher, MD | Abbott | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18056225 | Derived | Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
| ID | Term |
|---|---|
| C058254 | sibutramine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change from baseline in BMI |
| 6 months |
| Change from baseline in global improvement | 6 months |
| Change from baseline in eating pathology (TFEQ) | 6 months |
| Change from baseline in quality of life (IWQOL-Lite). | 6 months |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |