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A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

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

NCT03672175•Biogen

View on ClinicalTrials.gov

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).

Detailed Description

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
•2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria

•1. Participant had active psychosis.
•2. Participant had attempted suicide associated with the current episode of MDD.
•3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Locations (53)

Sage Investigational Site

Rogers, Arkansas, United States

Sage Investigational Site

Bellflower, California, United States

Sage Investigational Site

Garden Grove, California, United States

Sage Investigational Site

Glendale, California, United States

Sage Investigational Site

National City, California, United States

Sage Investigational Site

Oakland, California, United States

Sage Investigational Site

Oceanside, California, United States

Sage Investigational Site

Orange, California, United States

Sage Investigational Site

Pico Rivera, California, United States

Sage Investigational Site

Redlands, California, United States

Key Dates

Start Date

November 19, 2018

Primary Completion Date

September 24, 2019

Completion Date

March 17, 2020

Last Updated

November 29, 2023

Enrollment

581

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

SAGE-217

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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