NCT04442490

A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

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: 543 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.

Detailed description

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	SAGE-217	SAGE-217 oral capsules.
DRUG	Placebo	SAGE-217 matched-placebo oral capsules.

Timeline

• Start date: 2020-05-12
• Primary completion: 2021-03-26
• Completion: 2021-04-21
• First posted: 2020-06-22
• Last updated: 2023-12-22
• Results posted: 2023-12-05

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study