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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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03000530
Study type Interventional
Source Sage Therapeutics
Status Completed
Phase Phase 2
Start date December 7, 2016
Completion date November 8, 2017

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