A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the
 treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
Inclusion Criteria:

 -  Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and
 Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version
 (SCID-5-CT), with symptoms that have been present for at least a 4-week period

 -  HAM-D-17 total score of ≥24 at Screening and Day 1

 -  Participant 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

 -  Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified
 in the protocol (an eligible ADT is an ADT that has not been taken during the current
 depressive episode and for which the participant has no contraindications; further, a
 participant is not eligible for citalopram if escitalopram has been taken during the
 current depressive episode, and vice versa)

 Exclusion Criteria:

 -  Has attempted suicide associated with the current episode of MDD

 -  Participant had onset of the current depressive episode during pregnancy or 4 weeks
 postpartum, or the participant has presented for screening during the 6-month
 postpartum period

 -  Participant has treatment-resistant depression

 -  History of bipolar disorder, schizophrenia, and/or schizoaffective disorder

 -  Known allergy to SAGE-217, allopregnanolone, or related compounds

 -  Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine
 within 60 days prior to Day 1