Trials / Terminated
TerminatedNCT04007367
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
Detailed description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAGE-217 | SAGE-217 capsule |
| DRUG | Placebo | SAGE-217 matching placebo capsule |
Timeline
- Start date
- 2019-08-06
- Primary completion
- 2020-01-06
- Completion
- 2020-01-06
- First posted
- 2019-07-05
- Last updated
- 2023-11-29
- Results posted
- 2022-10-03
Locations
46 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04007367. Inclusion in this directory is not an endorsement.