Trials / Completed
CompletedNCT04476030
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 440 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
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 | Oral capsules |
| DRUG | Matching Placebo | Oral capsules |
| DRUG | Sertraline | Oral tablets |
| DRUG | Escitalopram | Oral tablets |
| DRUG | Citalopram | Oral tablets |
| DRUG | Duloxetine | Oral capsules |
| DRUG | Desvenlafaxine | Oral tablets |
Timeline
- Start date
- 2020-11-09
- Primary completion
- 2021-10-25
- Completion
- 2021-12-22
- First posted
- 2020-07-17
- Last updated
- 2023-12-22
- Results posted
- 2023-11-07
Locations
51 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04476030. Inclusion in this directory is not an endorsement.