A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder

NCT04007367 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: 217-MDD-3022019-002640-25
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 46

Brief Summary

This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

MDD; SAGE-217

Outcome Measures

Primary Outcomes (1)

• Time to Relapse During the DB Phase

  Time to relapse was defined as days from the first dose of the study drug in the DB Phase to the day of relapse during the DB Phase. Participant was considered to have relapsed if: 2 consecutive HAM-D scores were ≥ 18 assessed 7 to 14 days apart, any worsening of depression requiring hospitalization, Investigator-determined risk of suicide, or any other clinically relevant event whether or not hospitalization was required. HAM-D is a scale used to rate depression in participants who were already diagnosed as depressed. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia, somatic symptoms, genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 included: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety, hypochondriasis. The HAM-D total score could range from 0 (not depressed) to 52 (severely depressed). Higher scores indicated more depression.

  Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)

Secondary Outcomes (9)

• Percentage of Participants Who Relapsed During the DB Phase

  Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)

• Change From Baseline in the 17-Item HAM-D Total Score at the End of Each 14-Day Treatment Period in the DB Phase

  Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e., up to 22 weeks)

• Percentage of Participants With HAM-D Response at the End of Each 14-Day Treatment Period in the DB Phase

  Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)

• Percentage of Participants With HAM-D Remission at the End of Each 14-Day Treatment Period in the DB Phase

  Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)

• Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at the End of Each 14-Day Treatment Period in the DB Phase

  Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)

Study Arms (3)

Open-Label Phase: SAGE-217

EXPERIMENTAL

Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD) in the evening from Day 1 to Day 14.

Drug: SAGE-217

Double-Blind Phase: Placebo

PLACEBO COMPARATOR

Following the OL Phase, participants who exhibited a Hamilton Rating Scale for Depression (HAM-D) response, defined as a greater than or equal to (≥) 50% reduction from baseline in HAM-D total score were to be randomized to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, in a total of five, 14-day treatment periods, each separated by a 6-week follow-up period during the 40-week DB Phase of the study. However, no participants were randomized to receive SAGE-217 matching placebo due to early study termination.

Drug: Placebo

Double-Blind Phase: SAGE-217

EXPERIMENTAL

Following the OL Phase, participants who exhibited a HAM-D response defined as a ≥ 50% reduction from baseline in HAM-D total score to SAGE-217 were randomized to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, up to study termination date (i.e., up to approximately 22 weeks) during the DB Phase of the study.

Drug: SAGE-217

Interventions

SAGE-217 DRUG

SAGE-217 capsule

Double-Blind Phase: SAGE-217; Open-Label Phase: SAGE-217

Placebo DRUG

SAGE-217 matching placebo capsule

Double-Blind Phase: 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 as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
• Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
• Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) until after study completion.

You may not qualify if:

• Participant had attempted suicide associated with the current episode of MDD.
• Participant had 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. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
• Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.

Sponsors & Collaborators

• Biogen: lead

Study Sites (46)

Sage Investigational Site

Bentonville, Arkansas, 72712, 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

Lemon Grove, California, 91945, United States

Location

Sage Investigational Site

Oceanside, California, 92056, United States

Location

Sage Investigational Site

Orange, California, 92868, United States

Location

Sage Investigational Site

Riverside, California, 92503, United States

Location

Sage Investigational Site

San Diego, California, 92103, United States

Location

Sage Investigational Site

San Marcos, California, 92078, United States

Location

Sage Investigational Site

Sherman Oaks, California, 91403, United States

Location

Sage Investigational Site

Coral Springs, Florida, 33067, United States

Location

Sage Investigational Site

Jacksonville, Florida, 32256, United States

Location

Sage Investigational Site

Lauderhill, Florida, 33319, United States

Location

Sage Investigational Site

Orlando, Florida, 32801, 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, 30329, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Chicago, Illinois, 60634, United States

Location

Sage Investigational Site

Lincolnwood, Illinois, 60712, United States

Location

Sage Investigational Site

Lake Charles, Louisiana, 70629, United States

Location

Sage Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

Sage Investigational Site

Boston, Massachusetts, 02131, United States

Location

Sage Investigational Site

Methuen, Massachusetts, 01844, United States

Location

Sage Investigational Site

Watertown, Massachusetts, 02472, United States

Location

Sage Investigational Site

Ann Arbor, Michigan, 48109, 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

Cherry Hill, New Jersey, 08002, United States

Location

Sage Investigational Site

Marlton, New Jersey, 08053, United States

Location

Sage Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Sage Investigational Site

Jamaica, New York, 11432, United States

Location

Sage Investigational Site

New York, New York, 10017, United States

Location

Sage Investigational Site

New York, New York, 10128, United States

Location

Sage Investigational Site

Rochester, New York, 14618, United States

Location

Sage Investigational Site

Dayton, Ohio, 454117, 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

Allentown, Pennsylvania, 18104, United States

Location

Sage Investigational Site

Memphis, Tennessee, 38119, United States

Location

Sage Investigational Site

Austin, Texas, 78737, United States

Location

Sage Investigational Site

Dallas, Texas, 75231, 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

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

The study was stopped prematurely and therefore data was not collected and analyzed for any efficacy outcome measure planned for the DB Phase of the study.

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: August 6, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: November 29, 2023
• Results First Posted: October 3, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (46)