Clinical trial NCT04476030: A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Official title: A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
MDD
SAGE-217
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

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:

* Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
* 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
* Participant 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
* Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)

Exclusion Criteria:

* Has attempted suicide associated with the current episode of MDD
* Participant had 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 treatment-resistant depression
* History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
* Known allergy to SAGE-217, allopregnanolone, or related compounds
* Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1

Primary outcomes:
measure: Change From Baseline in the HAMD-17 Total Score at Day 3
timeFrame: Baseline, Day 3
Secondary outcomes:
measure: Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period
timeFrame: Baseline through Day 15
measure: Change From Baseline in the HAMD-17 Total Score at Days 15 and 42
timeFrame: Baseline, Days 15 and 42
measure: Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment
timeFrame: Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18)
measure: Percentage of Participants With HAMD-17 Response at Day 15 and Day 42
timeFrame: At Days 15 and 42
measure: Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42
timeFrame: Days 15 and 42
measure: Change From Baseline in CGI-S Score at Day 15
timeFrame: Baseline and Day 15
measure: Percentage of Participants With CGI-I Response, at Day 3 and Day 15
timeFrame: Days 3 and 15
measure: Change From Baseline in MADRS Total Score at Day 15
timeFrame: Baseline and Day 15
measure: Percentage of Participants With MADRS Response at Day 15
timeFrame: Day 15
measure: Percentage of Participants With MADRS Remission at Day 15
timeFrame: Day 15
measure: Change From Baseline in HAM-A Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Time to First HAMD-17 Response
timeFrame: From first dose of study drug up to first HAMD-17 response (up to approximately 65 days)
measure: Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9
timeFrame: Baseline and Day 15
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 58 weeks
measure: Percentage of Participants With TEAEs, Graded by Severity
timeFrame: Up to approximately 58 weeks
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: 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: Towson
country: United States
facility: Sage Investigational Site
state: Maryland
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: 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: