Clinical trial NCT04007367: A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
Official title: A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
SAGE-217
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Detailed description: This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
3. 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.

Exclusion Criteria:

1. Participant had attempted suicide associated with the current episode of MDD.
2. 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.
3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.

Primary outcomes:
measure: Time to Relapse During the DB Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
Secondary outcomes:
measure: Percentage of Participants Who Relapsed During the DB Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Change From Baseline in the 17-Item HAM-D Total Score at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Percentage of Participants With HAM-D Response at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Percentage of Participants With HAM-D Remission at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Change From Baseline in 9-Item Patient Health Questionnaire (PHQ-9) Score at the End of Each 14-Day Treatment Period in the DB Phase
timeFrame: Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e, up to 22 weeks)
measure: Time to Relapse During The DB Phase for Participants Who Achieved HAM-D Remission in the OL Phase
timeFrame: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first dose of study drug up to the end of the study (i.e., up to approximately 22 weeks)
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Bellflower
country: United States
facility: Sage Investigational Site
state: California
city: Garden Grove
country: United States
facility: Sage Investigational Site
state: California
city: Lemon Grove
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: San Marcos
country: United States
facility: Sage Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Sage Investigational Site
state: California
city: Coral Springs
country: United States
facility: Sage Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Sage Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
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: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
city: Lincolnwood
country: United States
facility: Sage Investigational Site
state: Illinois
city: Lake Charles
country: United States
facility: Sage Investigational Site
state: Louisiana
city: Gaithersburg
country: United States
facility: Sage Investigational Site
state: Maryland
city: Boston
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Methuen
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Sage Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Sage Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Sage Investigational Site
state: New Jersey
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: Albuquerque
country: United States
facility: Sage Investigational Site
state: New Mexico
city: Jamaica
country: United States
facility: Sage Investigational Site
state: New York
city: New York
country: United States
facility: Sage Investigational Site
state: New York
city: New York
country: United States
facility: Sage Investigational Site
state: New York
city: Rochester
country: United States
facility: Sage Investigational Site
state: New York
city: Dayton
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: Allentown
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Sage Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Sage Investigational Site
state: Texas
city: Dallas
country: United States
facility: Sage Investigational Site
state: Texas
city: Richardson
country: United States
facility: Sage Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Sage Investigational Site
state: Texas
city: Everett
country: United States
facility: Sage Investigational Site
state: Washington
Study officials:
References: