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A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

NCT ID: NCT04476030

Last Updated: 2023-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-12-22

Brief Summary

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The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

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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Depressive Disorder, Major

Keywords

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Major Depressive Disorder MDD SAGE-217

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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Placebo + Assigned ADT

Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Group Type ACTIVE_COMPARATOR

Matching Placebo

Intervention Type DRUG

Oral capsules

Sertraline

Intervention Type DRUG

Oral tablets

Escitalopram

Intervention Type DRUG

Oral tablets

Citalopram

Intervention Type DRUG

Oral tablets

Duloxetine

Intervention Type DRUG

Oral capsules

Desvenlafaxine

Intervention Type DRUG

Oral tablets

SAGE-217 + Assigned ADT

Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

Oral capsules

Sertraline

Intervention Type DRUG

Oral tablets

Escitalopram

Intervention Type DRUG

Oral tablets

Citalopram

Intervention Type DRUG

Oral tablets

Duloxetine

Intervention Type DRUG

Oral capsules

Desvenlafaxine

Intervention Type DRUG

Oral tablets

Interventions

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SAGE-217

Oral capsules

Intervention Type DRUG

Matching Placebo

Oral capsules

Intervention Type DRUG

Sertraline

Oral tablets

Intervention Type DRUG

Escitalopram

Oral tablets

Intervention Type DRUG

Citalopram

Oral tablets

Intervention Type DRUG

Duloxetine

Oral capsules

Intervention Type DRUG

Desvenlafaxine

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
* 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
* Participant 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
* Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)

Exclusion Criteria

* Has attempted suicide associated with the current episode of MDD
* Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
* Participant has treatment-resistant depression
* History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
* Known allergy to SAGE-217, allopregnanolone, or related compounds
* Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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

Site Status

Sage Investigational Site

San Diego, California, United States

Site Status

Sage Investigational Site

Temecula, California, United States

Site Status

Sage Investigational Site

Colorado Springs, Colorado, United States

Site Status

Sage Investigational Site

Cromwell, Connecticut, United States

Site Status

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

Orlando, Florida, United States

Site Status

Sage Investigational Site

Orlando, Florida, United States

Site Status

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

Towson, Maryland, 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

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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Parikh SV, Aaronson ST, Mathew SJ, Alva G, DeBattista C, Kanes S, Lasser R, Bullock A, Kotecha M, Jung J, Forrestal F, Jonas J, Vera T, Leclair B, Doherty J. Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study. Neuropsychopharmacology. 2024 Jan;49(2):467-475. doi: 10.1038/s41386-023-01751-9. Epub 2023 Oct 24.

Reference Type DERIVED
PMID: 37875578 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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217-MDD-305

Identifier Type: -

Identifier Source: org_study_id