JPRN-jRCT2080222269未知3 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
试验速览
- 阶段
- 3 期
- 入组人数
- 501
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
- >= 18age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
- •-Outpatients aged 18 through 74 years at the time of consent
- •-Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (more than 4 weeks and less than 12 months) without psychotic features
排除标准
- •-Patients with imminent risk of suicide or injury to self, others, or property.
- •-Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening.
- •-Patients who are otherwise considered ineligible for the study by the investigator.
研究者
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