A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Sage Therapeutics
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
Research Team
CS
Christopher Silber, MD
Principal Investigator
Sage Therapeutics
Eligibility Criteria
Inclusion Criteria
Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
Treatment Details
Interventions
- Placebo (Drug)
- SAGE-217 (GABA receptor modulator)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: SAGE-217Experimental Treatment1 Intervention
Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days.
Group II: Part A: SAGE-217Experimental Treatment1 Intervention
Participants received SAGE-217, 30 milligrams (mg), oral solution, once daily for 14 days, as tolerated.
Group III: Part B: PlaceboPlacebo Group1 Intervention
Eligible participants received matching placebo capsules once daily for 14 days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sage Investigational SiteGarden Grove, CA
Sage Investigational SiteAtlanta, GA
Sage Investigational SiteBerlin, NJ
Sage Investigational SiteCharlottesville, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Sage Therapeutics
Lead Sponsor
Trials
51
Patients Recruited
11,000+
Founded
2010
Headquarters
Cambridge, USA
Known For
Brain Health Medicines
Top Products
ZURZUVAE (zuranolone), SAGE-324
Biogen
Lead Sponsor
Trials
655
Patients Recruited
468,000+