JPRN-jRCT2080225269已完成2 期
ate Phase II Study of TS-142 in Patients with Insomnia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •To be eligible for study participation, an individual must meet all of the following criteria:
- •-Japanese male and female age 20 years or older at the time of informed consent
- •- Outpatients
- •- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
- •- Other protocol defined inclusion criteria could apply
排除标准
- •An individual who meets any of the following criteria will be excluded from participation
- •in this study:
- •- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
- •- Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
- •- Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
- •- Other protocol defined exclusion criteria could apply
研究者
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