NCT00413023已完成2 期
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 39
- 主要终点
- Change in score on a Depression rating scale following 8 weeks of treatment.
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 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
- 未提供
排除标准
- •Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
- •Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
- •Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
- •Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
- •Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).
结局指标
主要结局
Change in score on a Depression rating scale following 8 weeks of treatment.
次要结局
- Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.
研究者
研究点 (39)
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