NCT00057239已完成2 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects With Major Depressive Disorder for a Treatment Period of Eight Weeks
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 30
- 主要终点
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment
研究概览
简要总结
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in Patients with Major Depressive Disorder (MDD)
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder (MDD)
- •Duration of current depressive episode 12 weeks - 24 months
- •Patients can read and write at a level sufficient to provide a signed consent
- •If female, patients must be practicing an acceptable method of birth control
排除标准
- •Patients have other psychiatric disorders that would affect patient's response to treatment
- •Patients have not responded to two or more adequate courses of antidepressant therapy
- •Patients cannot be currently abusing illicit drugs or alcohol
- •Patients are not currently receiving psychotherapy
- •Patients have received electroconvulsive therapy within 6 months prior to screening
- •Patients are pregnant or lactating
结局指标
主要结局
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment
时间窗: 8 Weeks
次要结局
- Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study.(8 Weeks)
研究者
研究点 (30)
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