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

NCT ID: NCT03672175

Last Updated: 2023-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

581 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-03-17

Brief Summary

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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

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

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SAGE-217 Matched Placebo

Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matched placebo hard gelatin capsules.

SAGE-217 20 mg

Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 hard gelatin capsules.

SAGE-217 30 mg

Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 hard gelatin capsules.

Interventions

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SAGE-217

SAGE-217 hard gelatin capsules.

Intervention Type DRUG

Placebo

SAGE-217 matched placebo hard gelatin capsules.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Rogers, Arkansas, United States

Site Status

Sage Investigational Site

Bellflower, California, United States

Site Status

Sage Investigational Site

Garden Grove, California, United States

Site Status

Sage Investigational Site

Glendale, California, United States

Site Status

Sage Investigational Site

National City, California, United States

Site Status

Sage Investigational Site

Oakland, 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

Pico Rivera, California, United States

Site Status

Sage Investigational Site

Redlands, California, United States

Site Status

Sage Investigational Site

San Diego, California, United States

Site Status

Sage Investigational Site

Sherman Oaks, California, United States

Site Status

Sage Investigational Site

Temecula, California, United States

Site Status

Sage Investigational Site

Coral Springs, Florida, United States

Site Status

Sage Investigational Site

Hollywood, Florida, United States

Site Status

Sage Investigational Site

Jacksonville, Florida, United States

Site Status

Sage Investigational Site

Lauderhill, Florida, United States

Site Status

Sage Investigational Site

Maitland, Florida, United States

Site Status

Sage Investigational Site

North Miami, Florida, United States

Site Status

Sage Investigational Site

Orange City, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Sage Investigational Site

Atlanta, Georgia, United States

Site Status

Site Investigational Site

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Skokie, Illinois, United States

Site Status

Sage Investigational Site

Pikesville, Maryland, United States

Site Status

Sage Investigational Site

Flowood, Mississippi, United States

Site Status

Sage Investigational Site

Flowood, Mississippi, United States

Site Status

Sage Investigational Site

O'Fallon, Missouri, United States

Site Status

Sage Investigational Site

St Louis, Missouri, United States

Site Status

Sage Investigational Site

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Berlin, New Jersey, United States

Site Status

Sage Investigational Site

Jamaica, New York, United States

Site Status

Sage Investigational Site

Rochester, New York, United States

Site Status

Sage Investigational Site

Charlotte, North Carolina, United States

Site Status

Sage Investigational Site

Cincinnati, Ohio, United States

Site Status

Sage Investigational Site

Dayton, 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

Oklahoma City, Oklahoma, United States

Site Status

Sage Investigational Site

Portland, Oregon, United States

Site Status

Sage Investigational Site

Portland, Oregon, United States

Site Status

Sage Investigational Site

Allentown, Pennsylvania, United States

Site Status

Sage Investigational Site

Charleston, South Carolina, United States

Site Status

Sage Investigational Site

Memphis, Tennessee, United States

Site Status

Sage Investigational Site

Austin, Texas, United States

Site Status

Sage Investigational Site

Bellaire, Texas, United States

Site Status

Sage Investigational Site

DeSoto, Texas, United States

Site Status

Sage Investigational Site

Richardson, Texas, United States

Site Status

Sage Investigational Site

Wichita Falls, Texas, United States

Site Status

Sage Investigational Site

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Clayton AH, Lasser R, Nandy I, Sankoh AJ, Jonas J, Kanes SJ. Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial. J Clin Psychiatry. 2023 Feb 20;84(2):22m14445. doi: 10.4088/JCP.22m14445.

Reference Type DERIVED
PMID: 36811520 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.sagerx.com

Related Info

Other Identifiers

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217-MDD-301

Identifier Type: -

Identifier Source: org_study_id