NCT00402584已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 304
- 主要终点
- The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with 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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were men and women
- •between the ages of 18 and 65
- •with Body Mass Index (BMI) <45 kg/m2
- •who met DSM-IV criteria for BED
排除标准
- •Participants were excluded
- •for blood pressure >140/90 mm Hg
- •with pulse >95 beats/min
- •history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
- •use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
- •current participation in a weight loss program
- •surgical treatment for obesity
- •bulimia nervosa or purging in the past 6 months
- •alcohol or drug abuse in the past 12 months
- •current psychiatric condition being treated with a psychoactive agent
- •current major depressive disorder
- •history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts
- •psychotherapy within the previous 2 months
- •Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions
结局指标
主要结局
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
时间窗: 6 months
次要结局
- Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)(6 months)
- Change from baseline in Body Weight(6 months)
- Change from baseline in BMI(6 months)
- Change from baseline in global improvement(6 months)
- Change from baseline in eating pathology (TFEQ)(6 months)
- Change from baseline in quality of life (IWQOL-Lite).(6 months)
研究者
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