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

NCT04442490 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 217-MDD-301B
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 39

Brief Summary

The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.

Conditions

Depressive Disorder, Major

Keywords

Depression; Depressive disorder; SAGE-217

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 17-item HAM-D Total Score at Day 15

  The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change indicates improvement. A mixed Model for Repeated Measures (MMRM)was used for the analysis.

  Baseline, Day 15

Secondary Outcomes (10)

• Change From Baseline in the CGI-S Score at Day 15

  Baseline, Day 15

• Change From Baseline in the HAM-D Total Score at Days 3, 8 and 42

  Baseline, Days 3, 8, and 42

• Percentage of Participants Achieving HAM-D Response

  Days 15 and 42

• Percentage of Participants Achieving HAM-D Remission

  Days 15 and 42

• Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at Day 15

  Day 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SAGE-217 50 mg

EXPERIMENTAL

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.

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217 oral capsules.

SAGE-217 50 mg

Placebo DRUG

SAGE-217 matched-placebo oral capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
• 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.
• 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.

You may not qualify if:

• Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
• 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.
• 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.
• 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.
• Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• 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.
• Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.

Sponsors & Collaborators

• Biogen: lead

Study Sites (39)

Sage Investigational Site

Rogers, Arkansas, 72758, United States

Location

Sage Investigational Site

Bellflower, California, 90706, United States

Location

Sage Investigational Site

Garden Grove, California, 92845, United States

Location

Sage Investigational Site

Glendale, California, 91206, United States

Location

Sage Investigational Site

Lemon Grove, California, 91945, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Pico Rivera, California, 90660, United States

Location

Sage Investigational Site

Redlands, California, 92374, United States

Location

Sage Investigational Site

San Diego, California, 92103, United States

Location

Sage Investigational Site

Sherman Oaks, California, 91403, United States

Location

Sage Investigational Site

Temecula, California, 92591, United States

Location

Sage Investigational Site

Coral Springs, Florida, 33067, United States

Location

Sage Investigational Site

Hollywood, Florida, 33024, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32256, United States

Location

Sage Investigational Site

Lauderhill, Florida, 33319, United States

Location

Sage Investigational Site

Orange City, Florida, 32763, United States

Location

Sage Investigational Site

Orlando, Florida, 32801, United States

Location

Sage Investigational Site

Orlando, Florida, 32807, United States

Location

Sage Investigational Site

Alpharetta, Georgia, 30022, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30328, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Skokie, Illinois, 60076, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

O'Fallon, Missouri, 63368, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Marlton, New Jersey, 08053, United States

Location

Sage Investigational Site

Charlotte, North Carolina, 28211, United States

Location

Sage Investigational Site

Cincinnati, Ohio, 45215, United States

Location

Sage Investigational Site

Dayton, Ohio, 45417, United States

Location

Sage Investigational Site

North Canton, Ohio, 44720, United States

Location

Sage Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Sage Investigational Site

Portland, Oregon, 97210, United States

Location

Sage Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Sage Investigational Site

Charleston, South Carolina, 29407, United States

Location

Sage Investigational Site

Memphis, Tennessee, 38119, United States

Location

Sage Investigational Site

DeSoto, Texas, 75115, United States

Location

Sage Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Sage Investigational Site

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: May 12, 2020
• Primary Completion: March 26, 2021
• Study Completion: April 21, 2021
• Last Updated: December 22, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (39)