Status:
COMPLETED
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Lead Sponsor:
Biogen
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
Detailed Description
This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for 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.
- Participant is 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 has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).
Exclusion
- Participant has attempted suicide associated with the current episode of MDD.
- Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
1515 Patients enrolled
Trial Details
Trial ID
NCT03864614
Start Date
February 27 2019
End Date
June 22 2023
Last Update
August 27 2024
Active Locations (52)
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1
Sage Investigational Site
Dothan, Alabama, United States, 36303
2
Sage Investigational Site
Phoenix, Arizona, United States, 85012
3
Sage Investigational Site
Anaheim, California, United States, 92805
4
Sage Investigational Site
Costa Mesa, California, United States, 92626