A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder

• Status: Completed
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: All

Summary

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult subjects with major depressive disorder

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

Criteria

Inclusion Criteria:

1. Subject has a diagnosis of MDD with symptoms that have been present for at least a 4-week period.

2. Subject has a MADRS total score of ≥32 and a HAM-D total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Subject has active psychosis.

2. Subject has attempted suicide associated with the current episode of MDD.

3. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.