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A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder

NCT04007367•Biogen

View on ClinicalTrials.gov

Summary

This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults 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 as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
•2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
•3. Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) until after study completion.

Exclusion Criteria

•1. Participant had attempted suicide associated with the current episode of MDD.
•2. Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
•3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.

Locations (46)

Sage Investigational Site

Bentonville, Arkansas, United States

Sage Investigational Site

Bellflower, California, United States

Sage Investigational Site

Garden Grove, California, United States

Sage Investigational Site

Lemon Grove, California, United States

Sage Investigational Site

Oceanside, California, United States

Sage Investigational Site

Orange, California, United States

Sage Investigational Site

Riverside, California, United States

Sage Investigational Site

San Diego, California, United States

Sage Investigational Site

San Marcos, California, United States

Sage Investigational Site

Sherman Oaks, California, United States

Key Dates

Start Date

August 6, 2019

Primary Completion Date

January 6, 2020

Completion Date

January 6, 2020

Last Updated

November 29, 2023

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

SAGE-217

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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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 SAGE-217 for Prevention of Relapse in 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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