CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 543 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/NCT04442490
NCT04442490Phase 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 Jun 22, 2020·Updated Dec 22, 2023

In Brief

A Phase 3 clinical trial evaluating SAGE-217 and Placebo for Depressive Disorder, Major. Completed, enrolled 543 participants across 39 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 22, 2020
Enrollment StartMay 12, 2020
Primary CompletionMar 26, 2021
Study CompletionApr 21, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.0 years ago

Interventions

SAGE-217drug

SAGE-217 oral capsules.

Placebodrug

SAGE-217 matched-placebo oral capsules.