Clinical trial NCT03864614: A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Official title: A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 1515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

Detailed description: This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for 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 is 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.
3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant has attempted suicide associated with the current episode of MDD.
2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

Primary outcomes:
measure: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 52 Weeks
measure: Part B: Number of Participants With TEAEs
timeFrame: Up to 46 Weeks
measure: Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to 52 Weeks (Study Period 1-5)
measure: Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS
timeFrame: Baseline up to 46 Weeks (Study Period 1-5)
Secondary outcomes:
measure: Parts A and B: Time to First Repeat Treatment With SAGE-217
timeFrame: Up to 52 Weeks
measure: Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217
timeFrame: Up to 52 Weeks
measure: Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant
timeFrame: Up to 52 Weeks
measure: Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1
timeFrame: Baseline, Day 15 in Study Period 1
measure: Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle
timeFrame: Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
measure: Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle
timeFrame: Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5
measure: Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1
timeFrame: Day 15 of treatment cycle 1
measure: Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period
timeFrame: Day 15 of Study Period 2, 3, 4, and 5
measure: Part B: Percentage of Participants Who Achieved HAM-D Response
timeFrame: Day 15 of Study Period 1, 2, 3, 4, and 5
measure: Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1
timeFrame: Day 15 of treatment cycle 1
measure: Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period
timeFrame: Day 15 of Study Periods 2, 3, 4, and 5
measure: Part B: Percentage of Participants Who Achieved HAM-D Remission
timeFrame: Day 15 of Study Period 1, 2, 3, 4, and 5
measure: Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1
timeFrame: Day 15 of treatment cycle 1
measure: Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period
timeFrame: Day 15 of Study Periods 2, 3, 4, and 5
measure: Part B: Percentage of Participants Who Achieved CGI-I Response
timeFrame: Day 15 of Study Period 1, 2, 3, 4, and 5
measure: Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1
timeFrame: Baseline, Day 15 of treatment cycle 1
measure: Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle
timeFrame: Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
measure: Part B: Change From Baseline in CGI-S Score
timeFrame: Baseline Day 15 of Study Period 1, 2, 3, 4, and 5
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Sage Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Sage Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Sage Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Sage Investigational Site
state: California
city: Glendale
country: United States
facility: Sage Investigational Site
state: California
city: Irvine
country: United States
facility: Sage Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Sage Investigational Site
state: California
city: Oceanside
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Riverside
country: United States
facility: Sage Investigational Site
state: California
city: San Diego
country: United States
facility: Sage Investigational Site
state: California
city: Temecula
country: United States
facility: Sage Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Sage Investigational Site
state: Colorado
city: Cromwell
country: United States
facility: Sage Investigational Site
state: Connecticut
city: Norwich
country: United States
facility: Sage Investigational Site
state: Connecticut
city: Coral Springs
country: United States
facility: Sage Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Sage Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Sage Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
city: Watertown
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Sage Investigational Site
state: Michigan
city: Saint Charles
country: United States
facility: Sage Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Sage Investigational Site
state: Nebraska
city: Cherry Hill
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Marlton
country: United States
facility: Sage Investigational site
state: New Jersey
city: Princeton
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Sage Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Sage Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Sage Investigational Site
state: New York
city: Mount Kisco
country: United States
facility: Sage Investigational Site
state: New York
city: Beachwood
country: United States
facility: Sage Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Sage Investigational site
state: Ohio
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
city: North Canton
country: United States
facility: Sage Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Sage Investigational Site
state: Oklahoma
city: Plymouth Meeting
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Sage Investigational Site
state: Texas
city: Dallas
country: United States
facility: Sage Investigational Site
state: Texas
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: Newport
country: United States
facility: Sage Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Sage Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Sage Investigational Site
state: Washington
Study officials:
References: