A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for
 re-treatment with SAGE-217 in adult participants with MDD.
Inclusion Criteria:

 1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview
 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
 Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least
 a 4-week period.

 2. Participant is in good physical health and has no clinically significant findings, as
 determined by the Investigator, on physical examination, 12-lead electrocardiogram
 (ECG), or clinical laboratory tests.

 3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28
 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

 Exclusion Criteria:

 1. Participant has attempted suicide associated with the current episode of MDD.

 2. Participant has a medical history of bipolar disorder, schizophrenia, and/or
 schizoaffective disorder.

 3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken
 ketamine (including esketamine) within the current major depressive episode.