A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With Social Anxiety Disorder (SAD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Clinical Global Impression-Change (CGI-C)
研究概览
简要总结
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
详细描述
This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Primary diagnosis of SAD
- •CGI (S) ≥ 4 at screen
- •LSAS ≥ 50 at baseline
- •Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen
排除标准
- •Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
- •HAM-D ≥15 or a score of >2 on Item 1 at baseline
- •Serious or unstable medical condition
- •Alcohol or substance use disorder within 6 months prior to study
结局指标
主要结局
Clinical Global Impression-Change (CGI-C)
Liebowitz Social Anxiety Scale (LSAS)
次要结局
- Hamilton Anxiety Scale (HAM-A)
- Social Phobia Inventory (SPIN)
- Pittsburgh Sleep Quality Index (PSQI)
- 36-Item Short-Form Health Survey (SF-36)
- Clinical Global Impression-S (CGI-S).