NCT00273039已完成2 期
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Social Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 27
- 主要终点
- The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of GW679769 and paroxetine in subjects with Social 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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Generalized Social Anxiety Disorder as the primary diagnosis.
- •If female, must commit to consistent and correct use of an acceptable method of birth control.
排除标准
- •Patients with any other psychiatric disorder as a primary diagnosis or within 6 months prior to screening.
- •Patients with Body Dysmophic Disorder, Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder.
- •Patients who pose a current suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
- •Patients who have a positive urine test at screen for illegal drug use and/or a history of substance abuse or dependence (alcohol or drugs) within the past 12 months.
- •Patients with an unstable medical disorder.
- •Female patients who are pregnant, lactating, or planning to become pregnant during a specified time during the study.
- •Patients who are taking other psychoactive medications.
结局指标
主要结局
The primary outcome measure will be the change from baseline in the Liebowitz Social Anxiety Scale (LSAS)
次要结局
- Secondary outcome measures include the change from baseline in the following scales: the Clinical Global Impression-Global Improvement, the Clinical Global Impression -Severity of Illness, and the Sheehan Disability Scale.
研究者
研究点 (27)
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