Trials / Completed
CompletedNCT03864614
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,515 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAGE-217 | SAGE-217 |
Timeline
- Start date
- 2019-02-27
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
- First posted
- 2019-03-06
- Last updated
- 2024-08-27
- Results posted
- 2024-07-18
Locations
52 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03864614. Inclusion in this directory is not an endorsement.