Trials / Completed
CompletedNCT03672175
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 581 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants 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 hard gelatin capsules. |
| DRUG | Placebo | SAGE-217 matched placebo hard gelatin capsules. |
Timeline
- Start date
- 2018-11-19
- Primary completion
- 2019-09-24
- Completion
- 2020-03-17
- First posted
- 2018-09-14
- Last updated
- 2023-11-29
- Results posted
- 2022-11-10
Locations
53 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03672175. Inclusion in this directory is not an endorsement.