NCT00135421已完成1 期
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
Bristol-Myers Squibb40 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 40
- 主要终点
- Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
研究概览
简要总结
The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
- •Patients whose current depressive episode is at least three months in duration at the Baseline Visit.
排除标准
- •Patients with treatment resistance to other antidepressants
研究组 & 干预措施
A1
Experimental
干预措施: Pexacerfont (Drug)
A2
Active Comparator
干预措施: Escitalopram (Drug)
A3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
时间窗: Week 8
次要结局
- Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests(every visit and endpoint)
- Compare efficacy of escitalopram to placebo(at endpoint and at each visit)
研究者
研究点 (40)
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