Trials / Completed
CompletedNCT04442503
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults With Severe Postpartum Depression
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Biogen · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
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 oral capsules. |
| DRUG | Placebo | SAGE-217 matched-placebo oral capsules. |
Timeline
- Start date
- 2020-06-08
- Primary completion
- 2022-03-15
- Completion
- 2022-04-12
- First posted
- 2020-06-22
- Last updated
- 2023-11-30
- Results posted
- 2023-06-22
Locations
82 sites across 3 countries: United States, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04442503. Inclusion in this directory is not an endorsement.