Binge Eating Disorder, Obesity
Conditions
Keywords
Binge eating, Obesity, Medication, Craving, Emotional eating
Brief summary
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.
Detailed description
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.
Interventions
DRUGbupropion
300 mg per day for 8 weeks
OTHERPlacebo
Placebo
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI 25-50 * Able to travel to clinical site (New Haven, CT) for bi-weekly visits.
Exclusion criteria
* Predisposition to seizures * History of anorexia or bulimia nervosa * Current Type I or Type II diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Binge Eating Episodes | One week (at post treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent BMI Loss | 8 weeks (baseline and 8 weeks) | Percent loss in Body Mass Index |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Bupropion Bupropion
bupropion : 300 mg per day for 8 weeks | 31 |
| Placebo Placebo
Placebo : Placebo | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Bupropion | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 30 Participants | 61 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.1 | 43.1 years STANDARD_DEVIATION 13 | 44.2 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Frequency of Binge Eating Episodes
Time frame: One week (at post treatment)
Population: Baseline forward imputation for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion | Frequency of Binge Eating Episodes | 0.8 episodes/week | Standard Deviation 1.2 |
| Placebo | Frequency of Binge Eating Episodes | 1.0 episodes/week | Standard Deviation 1.5 |
Secondary
Percent BMI Loss
Percent loss in Body Mass Index
Time frame: 8 weeks (baseline and 8 weeks)
Population: Baseline values imputed forward for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion | Percent BMI Loss | 1.8 Percent loss | Standard Deviation 2.6 |
| Placebo | Percent BMI Loss | 0.6 Percent loss | Standard Deviation 2.1 |