A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

• Status: Completed
• Trial end date: 2017-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sage Therapeutics

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)

Exclusion Criteria:

• Participant has a history of suicide attempt

• Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time

• Participant has active psychosis

• Participant has a medical history of seizures

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