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

NCT03672175 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 217-MDD-301
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 53

Brief Summary

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 items scored in a range of 0 to 2 include: Insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following 9 items are scored in a range of 0 to 4: Agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression.

  Baseline (BL), Day 15

Secondary Outcomes (29)

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15

  Baseline, Day 15

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

  Baseline, Days 3, 8, 42, and 182

• Number of Participants Achieving HAM-D Response

  Days 15, 42, and 182

• Number of Participants Achieving HAM-D Remission

  Days 15, 42, and 182

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

  Day 15

Study Arms (3)

SAGE-217 Matched Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

SAGE-217 20 mg

EXPERIMENTAL

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

Drug: SAGE-217

SAGE-217 30 mg

EXPERIMENTAL

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

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217 hard gelatin capsules.

SAGE-217 20 mg; SAGE-217 30 mg

Placebo DRUG

SAGE-217 matched placebo hard gelatin capsules.

SAGE-217 Matched Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
• 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).

You may not qualify if:

• Participant had active psychosis.
• Participant had attempted suicide associated with the current episode of MDD.
• Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Sponsors & Collaborators

• Biogen: lead

Study Sites (53)

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

National City, California, 91950, United States

Location

Sage Investigational Site

Oakland, California, 94607, United States

Location

Sage Investigational Site

Oceanside, California, 92054, 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

Maitland, Florida, 32750, United States

Location

Sage Investigational Site

North Miami, Florida, 33161, 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

Atlanta, Georgia, 30328, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30341, United States

Location

Site Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Skokie, Illinois, 60076, United States

Location

Sage Investigational Site

Pikesville, Maryland, 21208, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39110, 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

St Louis, Missouri, 63141, United States

Location

Sage Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Sage Investigational Site

Berlin, New Jersey, 08009, United States

Location

Sage Investigational Site

Jamaica, New York, 11432, United States

Location

Sage Investigational Site

Rochester, New York, 14618, 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, 73106, 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

Portland, Oregon, 97214, 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

Austin, Texas, 78754, United States

Location

Sage Investigational Site

Bellaire, Texas, 77401, United States

Location

Sage Investigational Site

DeSoto, Texas, 75115, United States

Location

Sage Investigational Site

Richardson, Texas, 75080, United States

Location

Sage Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Sage Investigational Site

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 36811520 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

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: September 12, 2018
• First Posted: September 14, 2018
• Study Start: November 19, 2018
• Primary Completion: September 24, 2019
• Study Completion: March 17, 2020
• Last Updated: November 29, 2023
• Results First Posted: November 10, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (53)