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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK071646 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
This research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. Participants in the study will receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for eight weeks. In addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. This treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost.
It is expected that compared to placebo, bupropion will produce greater reductions in binge eating.
The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge eating episodes, bupropion is a promising psychopharmacological agent in treating binge eating and reducing weight. It is hypothesized that compared to placebo, bupropion will produce significantly greater reductions in the frequency of binge eating. Secondary goals are to explore interrelationships between treatment and changes in cravings, frequency of binge episodes, emotional eating, and weight loss. Following the medication phase of the trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered by doctoral-level psychologists specializing in eating disorders and weight management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bupropion |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupropion | Drug | 300 mg per day for 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Binge Eating Episodes | One week (at post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent BMI Loss | Percent loss in Body Mass Index | 8 weeks (baseline and 8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marney A. White, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23656848 | Derived | White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Apr;74(4):400-6. doi: 10.4088/JCP.12m08071. |
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Sixty-one overweight and obese women with BED were recruited from the community via advertisements. Participants were enrolled from November 2006 to December 2010. Assessments and clinic appointments were held in a medical school research clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupropion (300 mg/d) | Bupropion bupropion : 300 mg per day for 8 weeks |
| FG001 | Placebo | Placebo Placebo : Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupropion | Bupropion bupropion : 300 mg per day for 8 weeks |
| BG001 | Placebo | Placebo Placebo : Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Frequency of Binge Eating Episodes | Baseline forward imputation for missing data. | Posted | Mean | Standard Deviation | episodes/week | One week (at 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 | Bupropion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marney A. White | Yale University School of Medicine | 203-785-4349 | marney.white@yale.edu |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D009765 | Obesity |
| D002032 | Bulimia |
| D000098382 | Emotional Eating |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Placebo | Other | Placebo |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Percent BMI Loss | Percent loss in Body Mass Index | Baseline values imputed forward for missing data. | Posted | Mean | Standard Deviation | Percent loss | 8 weeks (baseline and 8 weeks) |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Placebo | 0 | 30 | 0 | 30 |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D005247 | Feeding Behavior |
| D001519 | Behavior |