Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Liebowitz Social Anxiety Scale (LSAS) - total score
研究概览
简要总结
The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.
详细描述
The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Social Anxiety Disorder, generalized subtype
- •LSAS total score of 70 at visits 1 and 2
排除标准
- •Lifetime history of Bipolar disorder or Schizophrenia
- •Current suicidal risk
- •Current unstable medical condition
研究组 & 干预措施
Vilazodone
Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks
干预措施: Vilazodone (Drug)
Placebo
Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Liebowitz Social Anxiety Scale (LSAS) - total score
时间窗: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.
次要结局
- Change on the LSAS anxiety and avoidance subscales(Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks)
- Change in Hamilton Depression scale total(Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks)
- Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2(Study Endpoint: minimum 6 weeks - maximum 12 weeks)
- Change in the Clinical Global Impression of Severity of Illness score(Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks)
- Change in Hamilton Anxiety scale total(Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks)
- Subject-assessed responder rate(Study Endpoint: minimum 6 weeks - maximum 12 weeks)