NCT02317744已完成不适用
Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Binge Eating Frequency (Continuous)
研究概览
简要总结
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- •BMI between 30 kg/m2 and 50 kg/m2
- •Not taking anti-depressant medications
- •Read English proficiently enough to read study assessments
- •Available for duration of treatment plus follow-up period
- •Able to travel to study location (New Haven, CT) for monthly visits
- •Agree to study procedures
排除标准
- •Medical status judged by study physician as contraindication
- •History of seizures
- •Past or current anorexia nervosa, bulimia nervosa
- •Current medications that influence eating/weight
- •Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
- •Pregnant or breastfeeding
研究组 & 干预措施
Naltrexone/ Bupropion combination
Experimental
50 mg naltrexone and 300 mg bupropion per day for 3 months
干预措施: Naltrexone and bupropion combination (Drug)
Pill placebo
Placebo Comparator
Daily placebo medication for 3 months
干预措施: Pill Placebo (Other)
结局指标
主要结局
Binge Eating Frequency (Continuous)
时间窗: 6 month follow-up (an average of 6 months following treatment)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
次要结局
- Body Mass Index (BMI)(6 month follow-up (an average of 6 months following treatment))
研究者
研究点 (1)
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