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

Major Depression Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03000530
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 2
Start date December 7, 2016
Completion date November 8, 2017
View Details
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