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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK073542-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sibutramine | Experimental | Sibutramine 15 mg daily |
|
| Placebo | Placebo Comparator | Placebo Daily |
|
| Placebo/CBTsh | Experimental | Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating |
|
| Sibutramine/CBTsh | Experimental | Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sibutramine | Drug | 15 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Binge Eating (Remission) | Remission from binge eating (zero binge episodes during previous 28 days) | 4 months treatment; 6 and 12 month follow up post treatment |
| BMI | BMI (kg/m^2) was measured 4 months after treatment. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M. Grilo, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Internal Medicine Associates (YIMA) | New Haven | Connecticut | 06510 | United States | ||
| Yale-New Haven Hospital (YNHH) Primary Care Center (PCC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24857821 | Result | Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2. | |
| 26214545 | Derived | Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sibutramine | Sibutramine 15 mg daily Sibutramine: 15 mg daily |
| FG001 | Placebo | Placebo Daily Placebo: Daily |
| FG002 | Placebo/CBTsh | Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily |
| FG003 | Sibutramine/CBTsh | Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sibutramine | Sibutramine 15 mg daily Sibutramine: 15 mg daily |
| BG001 | Placebo | Placebo Daily Placebo: Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binge Eating (Remission) | Remission from binge eating (zero binge episodes during previous 28 days) | Posted | Number | participants | 4 months treatment; 6 and 12 month follow up post treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sibutramine | Sibutramine 15 mg daily Sibutramine: 15 mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated blood pressure | Vascular disorders | Systematic Assessment | Patients medically withdrawn due to elevation in blood pressure during treatment (i.e., in excess of 145/90 BP, 100 pulse) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Grilo | Yale University School of Medicine | 2037852792 | carlos.grilo@yale.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C058254 | sibutramine |
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| Placebo |
| Drug |
Daily |
|
| Self-help CBT + Sibutramine | Behavioral | Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily |
|
| Self-help CBT + Placebo | Behavioral | Cognitive behavioral treatment manual for binge eating Placebo daily |
|
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Yale Psychiatric Research at Congress Place | New Haven | Connecticut | 06519 | United States |
| 25622201 | Derived | Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26. |
| Medically withdrawn |
|
| BG002 |
| Placebo/CBTsh |
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily |
| BG003 | Sibutramine/CBTsh | Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Age at onset of Binge Eating Disorder (BED) | Mean | Standard Deviation | years |
|
| OG003 | Sibutramine/CBTsh | Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily |
|
|
|
| Primary | BMI | BMI (kg/m^2) was measured 4 months after treatment. | Participants with complete data reported here (i.e., no imputation) | Posted | Mean | Standard Deviation | BMI (kg/m^2) | 4 months |
|
|
|
| 0 |
| 26 |
| 1 |
| 26 |
| EG001 | Placebo | Placebo Daily Placebo: Daily | 0 | 27 | 2 | 27 |
| EG002 | Placebo/CBTsh | Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily | 0 | 25 | 0 | 25 |
| EG003 | Sibutramine/CBTsh | Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily | 0 | 26 | 1 | 26 |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |