A Study to Evaluate SAGE-217 in Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode - Part A
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Sage Therapeutics
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信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 12, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | August 19, 2018 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
The safety and tolerability of SAGE-217 as assessed by the frequency and severity of adverse events.[ Time Frame: 14 Days ] The safety and tolerability of SAGE-217 as assessed by suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS).[ Time Frame: 14 Days ] The safety and tolerability of SAGE-217 as assessed by mania using the Young Mania Rating Scale (YMRS).[ Time Frame: 14 Days ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study to Evaluate SAGE-217 in Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode - Part A | ||
| 正式标题 ICMJE | A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode | ||
| 简要概况 | This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of subjects with bipolar I/II disorder with a current major depressive episode. |
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| 详细说明 | This posting addresses Part A | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Active, not recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 2019 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Subject has a documented history of hypomanic or manic episode and a diagnosis of bipolar I or bipolar II disorder with a current major depressive episode. Exclusion Criteria: 1. Subject has a history of suicide attempt. 2. Subject has current suicidal ideation with plans. 3. Subject has a history of rapid cycling bipolar disorder. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Sage Therapeutics | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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