NCT01131559终止3 期
Adjunctive Lisdexamfetamine in Bipolar Depression
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
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in MADRS score
研究概览
简要总结
The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar 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
- •Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,
排除标准
- •Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
- •Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
研究组 & 干预措施
Lisdexamfetamine
Active Comparator
Drug
干预措施: Lisdexamfetamine (Drug)
Placebo
Placebo Comparator
Drug
干预措施: Placebo control (Drug)
结局指标
主要结局
Change in MADRS score
时间窗: 30-36 months
The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.
次要结局
未报告次要终点
研究者
研究点 (1)
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