EUCTR2019-002640-25-GB进行中（未招募）1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF SAGE-217 WITH FIXED, REPEATED TREATMENT REGIMEN ON RELAPSE PREVENTION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 546
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.
- •2.Subject has had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
- •3.Subject is willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 541
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Subject has attempted suicide associated with the current episode of MDD
- •2.Subject has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be used for this purpose.
- •3.Subject has a positive pregnancy test at screening or on Day 1 prior to dosing.
研究者
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