jRCT2031230152进行中（未招募）不适用
A Phase 2/3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP 363856 in the Treatment of Adults with Generalized Anxiety Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •Male or female subject between 18 to 65 years of age.
- •Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder.
- •Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.
排除标准
- •Subject has DSM-5-based diagnosis of any disorder other than GAD that was the primary focus of treatment within 12 months before Screening.
- •Subjects who report an inadequate response to more than 3 antidepressant treatments.
- •Subject is at significant risk of harming self or others based on Investigator's judgment.
- •Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- •Female subject who is pregnant, lactating, or plans to get pregnant during the study.
结局指标
主要结局
-
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint (Week 8)
次要结局
未报告次要终点
研究者
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