NCT01090713已完成3 期
Lisdexamfetamine in Binge Eating Disorder of Moderate or Greater Severity
Lindner Center of HOPE1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- frequency of binge eating episode
研究概览
简要总结
The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will meet DSM-IV criteria for BED for at least the last 6 months
排除标准
- •Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
- •Subjects who are displaying clinically significant suicidality or homicidality.
- •A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence
研究组 & 干预措施
Lisdexamfetamine
Active Comparator
drug
干预措施: lisdexamfetamine (Drug)
Placebo
Placebo Comparator
Placebo comparator
干预措施: Placebo control (Drug)
结局指标
主要结局
frequency of binge eating episode
时间窗: 12 weeks
frequency of binge eating episode
次要结局
未报告次要终点
研究者
研究点 (1)
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