Overview

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sage Therapeutics
Treatments:
Citalopram
Desvenlafaxine Succinate
Duloxetine Hydrochloride
Sertraline
Criteria
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