CTIS2022-500538-27-00招募中1 期
A Phase 2/3, Multicenter, Randomized, Double blind, Placebo controlled Trial of the Safety and Efficacy of Flexible Doses of SEP 363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder. - 382-201-00001
Otsuka Pharmaceutical Development And Commercialization Inc.0 个研究点目标入组 900 人开始时间: 2022年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •The study population includes subjects 18 to 65 years of age inclusive at the time of consent with MDD as the main diagnosis and who are currently experiencing a major depressive episode (MDE) as determined by the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and appropriate clinical psychiatric assessment. The current MDE must have a duration of = 8 weeks and < 2 years. In addition, subjects must have reported a history for the current MDE of an inadequate response to at least 1 and no more than 3 adequate ADTs. Subjects must also have a total score = 18 at the screening and baseline visit on the 17-item Hamilton Depression Rating Scale (HAM-D17).
排除标准
- •Any subject who, in the opinion of the clinical trial sponsor, investigator, or medical monitor, should not participate in the trial will be excluded.
研究者
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