NCT00403962已完成2 期
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Comparing the Efficacy and Safety of GW597599/Paroxetine Combination or Paroxetine Monotherapy to Placebo in Patients With Social Anxiety Disorder (SAD)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 18
- 主要终点
- Change in score on a Social Anxiety Disorder rating scale following 12 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 a combination of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)
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
- •Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV.
- •Capable of giving informed consent and willing to comply with the study requirements.
- •Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.
排除标准
- •Primary diagnosis within the past 6 months of another Axis 1 disorder such as Major Depression or another 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 Social Anxiety Disorder rating scale following 12 weeks of treatment.
次要结局
- Change in score on a number of rating scales following 12 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 (18)
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