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

Sage Therapeutics, Inc.0 个研究点目标入组 546 人开始时间: 2019年11月25日最近更新: 2021年7月5日

适应症

试验速览

暂无简介。

•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

•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.

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