NCT03000530

A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder

A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Adult Subjects With Moderate to Severe Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.

Detailed description

Part A of the study is an open-label design with dosing of SAGE-217 for 14 days. Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days. This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	SAGE-217
DRUG	Placebo

Timeline

• Start date: 2016-12-07
• Primary completion: 2017-10-04
• Completion: 2017-11-08
• First posted: 2016-12-22
• Last updated: 2023-11-28
• Results posted: 2020-12-02

Locations

8 sites across 1 country: United States