Trials / Terminated
TerminatedNCT03771664
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
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 | Administered as capsules. |
| DRUG | Placebo | Administered as capsules. |
Timeline
- Start date
- 2019-02-04
- Primary completion
- 2019-12-20
- Completion
- 2020-01-17
- First posted
- 2018-12-11
- Last updated
- 2023-11-29
- Results posted
- 2022-10-20
Locations
28 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03771664. Inclusion in this directory is not an endorsement.