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A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

NCT ID: NCT04442490

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

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2021-04-21

Brief Summary

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The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with 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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Depressive Disorder, Major

Keywords

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Depression Depressive disorder 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

Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SAGE-217 matched-placebo oral capsules.

SAGE-217 50 mg

Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator.

Group Type EXPERIMENTAL

SAGE-217

Intervention Type DRUG

SAGE-217 oral capsules.

Interventions

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SAGE-217

SAGE-217 oral capsules.

Intervention Type DRUG

Placebo

SAGE-217 matched-placebo oral capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and 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 has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.
4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.

Exclusion Criteria

1. Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
2. Participant has 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.
3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m\^2 at Screening, which is subject to a broader evaluation of medical comorbidities.
4. Participant has 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.
5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.
7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.
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

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

Lemon Grove, 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

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

Alpharetta, Georgia, 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

Decatur, Georgia, United States

Site Status

Sage Investigational Site

Skokie, Illinois, 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

Las Vegas, Nevada, United States

Site Status

Sage Investigational Site

Marlton, New Jersey, 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

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

DeSoto, 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

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-301B

Identifier Type: -

Identifier Source: org_study_id