NCT00481325已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Bristol-Myers Squibb50 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 50
- 主要终点
- Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
研究概览
简要总结
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety 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 ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)
排除标准
- •Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
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 Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
时间窗: Week 8
次要结局
- Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score(Week 8)
- Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score(Week 8)
研究者
研究点 (50)
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