A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 oral capsules.; SAGE-217 matched-placebo oral capsules.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 543.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Depression; Depressive disorder; SAGE-217

Summary:

      The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of
      participants with MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for
             Diagnostic and 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 has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at
             screening and Day 1 (prior to dosing).

          3. Participants taking antidepressants must have been taking these medications at the
             same dose for at least 60 days prior to Day 1. Participants who have stopped taking
             antidepressants within 60 days must have stopped for longer than 5 half-lives of the
             antidepressant prior to Day 1. Participants receiving psychotherapy must have been
             receiving therapy on a regular schedule for at least 60 days prior to Day 1.

          4. Participant is willing to delay start of other antidepressant or antianxiety
             medications and any new pharmacotherapy regimens, including as-needed benzodiazepine
             anxiolytics and sleep aids, until after completion of the Day 42 visit.

        Exclusion Criteria:

          1. Participant is currently at significant risk of suicide, as judged by the
             Investigator, or has attempted suicide associated with the current episode of MDD.

          2. Participant has 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.

          3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m^2 at Screening, which is
             subject to a broader evaluation of medical comorbidities.

          4. Participant 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.

          5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or
             schizoaffective disorder.

          6. Participant has a history of mild, moderate, or severe substance use disorder
             (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to
             screening.

          7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids,
             regularly or as-needed, at Day -28.