Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Frequency of Binge Eating Episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI 25-50
- •Able to travel to clinical site (New Haven, CT) for bi-weekly visits.
排除标准
- •Predisposition to seizures
- •History of anorexia or bulimia nervosa
- •Current Type I or Type II diabetes mellitus
研究组 & 干预措施
1
Bupropion
干预措施: bupropion (Drug)
2
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of Binge Eating Episodes
时间窗: One week (at post treatment)
次要结局
- Percent BMI Loss(8 weeks (baseline and 8 weeks))