drugset / Trial / NCT04442490
A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
Timeline
- Start
- 2020-05-12
- Primary completion
- 2021-03-26
- Completion
- 2021-04-21
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs SAGE-217 50 mg; p = 0.0141; Least Squares (LS) Mean Difference -1.7 (95% CI -3.1 to -0.3); MMRM NCT04442490 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zuranolone | Small molecule | 40 mg | Oral |
| Subject | Zuranolone | Small molecule | 50 mg | Oral |