CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 581 enrolled
Drug / intervention
SAGE-217 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03672175
NCT03672175Phase 3Completed

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

Biogen·interventional·Posted Sep 14, 2018·Updated Nov 29, 2023

In Brief

A Phase 3 clinical trial evaluating SAGE-217 and Placebo for Major Depressive Disorder. Completed, enrolled 581 participants across 53 sites.

Detailed Summary

This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartNov 19, 2018
Primary CompletionSep 24, 2019
Study CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.8 years ago

Interventions

SAGE-217drug

SAGE-217 hard gelatin capsules.

Placebodrug

SAGE-217 matched placebo hard gelatin capsules.