2022-502077-42-00招募中3 期
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
Otsuka Pharmaceutical Development & Commercialization Inc.29 个研究点 分布在 6 个国家目标入组 255 人开始时间: 2023年7月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 29
- 主要终点
- Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.
研究概览
简要总结
To evaluate the efficacy of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in subjects with GAD as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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 a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than Generalized Anxiety Disorder, that is the primary focus of treatment
- •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 judgement.
- •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.
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.
次要结局
- Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint.
研究者
Brian Rothman
Scientific
Otsuka Pharmaceutical Development & Commercialization Inc.
研究点 (29)
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