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A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

NCT ID: NCT03864614

Last Updated: 2024-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2023-06-22

Brief Summary

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This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

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Detailed Description

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This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAGE-217

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217

Interventions

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SAGE-217

SAGE-217

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria

1. Participant has attempted suicide associated with the current episode of MDD.
2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sage Investigational Site

Dothan, Alabama, United States

Site Status

Sage Investigational Site

Phoenix, Arizona, United States

Site Status

Sage Investigational Site

Anaheim, California, United States

Site Status

Sage Investigational Site

Costa Mesa, California, United States

Site Status

Sage Investigational Site

Glendale, California, United States

Site Status

Sage Investigational Site

Irvine, California, United States

Site Status

Sage Investigational Site

Los Alamitos, California, United States

Site Status

Sage Investigational Site

Oceanside, California, United States

Site Status

Sage Investigational Site

Orange, California, United States

Site Status

Sage Investigational Site

Riverside, California, United States

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Sage Investigational Site

San Diego, California, United States

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Sage Investigational Site

Temecula, California, United States

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Sage Investigational Site

Colorado Springs, Colorado, United States

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Sage Investigational Site

Cromwell, Connecticut, United States

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Sage Investigational Site

Norwich, Connecticut, United States

Site Status

Sage Investigational Site

Coral Springs, Florida, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Miami, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

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Sage Investigational Site

Orlando, Florida, United States

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Sage Investigational Site

Pensacola, Florida, United States

Site Status

Sage Investigational Site

Alpharetta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Marietta, Georgia, United States

Site Status

Sage Investigational Site

Savannah, Georgia, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Chicago, Illinois, United States

Site Status

Sage Investigational Site

Watertown, Massachusetts, United States

Site Status

Sage Investigational Site

Ann Arbor, Michigan, United States

Site Status

Sage Investigational Site

Saint Charles, Missouri, United States

Site Status

Sage Investigational Site

Lincoln, Nebraska, United States

Site Status

Sage Investigational Site

Cherry Hill, New Jersey, United States

Site Status

Sage Investigational site

Marlton, New Jersey, United States

Site Status

Sage Investigational Site

Princeton, New Jersey, United States

Site Status

Sage Investigational Site

Albuquerque, New Mexico, United States

Site Status

Sage Investigational Site

Brooklyn, New York, United States

Site Status

Sage Investigational Site

Brooklyn, New York, United States

Site Status

Sage Investigational Site

Mount Kisco, New York, United States

Site Status

Sage Investigational Site

Beachwood, Ohio, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

North Canton, Ohio, United States

Site Status

Sage Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Sage Investigational Site

Plymouth Meeting, Pennsylvania, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Sage Investigational Site

Dallas, Texas, United States

Site Status

Sage Investigational Site

Houston, Texas, United States

Site Status

Sage Investigational Site

Houston, Texas, United States

Site Status

Sage Investigational Site

Newport, Texas, United States

Site Status

Sage Investigational Site

Wichita Falls, Texas, United States

Site Status

Sage Investigational Site

Bellevue, Washington, United States

Site Status

Countries

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United States

References

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Cutler AJ, Mattingly GW, Kornstein SG, Aaronson ST, Lasser R, Zhang H, Rana N, Brown C, Levin S, Miller C, Kotecha M, Forrestal F, Doherty J. Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study. J Clin Psychiatry. 2023 Dec 27;85(1):23m14845. doi: 10.4088/JCP.23m14845.

Reference Type DERIVED
PMID: 38153320 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Part A: Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan: Part B: Statistical Analysis Plan

View Document

Other Identifiers

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217-MDD-303

Identifier Type: -

Identifier Source: org_study_id

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