Clinical trial NCT04442490: A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression
Depressive disorder
SAGE-217
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 543
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 purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with 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 with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and 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 has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.
4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.

Exclusion Criteria:

1. Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
2. Participant has 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.
3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m\^2 at Screening, which is subject to a broader evaluation of medical comorbidities.
4. Participant has 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.
5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.
7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.

Primary outcomes:
measure: Change From Baseline in the 17-item HAM-D Total Score at Day 15
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Change From Baseline in the CGI-S Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in the HAM-D Total Score at Days 3, 8 and 42
timeFrame: Baseline, Days 3, 8, and 42
measure: Percentage of Participants Achieving HAM-D Response
timeFrame: Days 15 and 42
measure: Percentage of Participants Achieving HAM-D Remission
timeFrame: Days 15 and 42
measure: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at Day 15
timeFrame: Day 15
measure: Change From Baseline in MADRS Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in HAM-A Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Time to First HAM-D Response
timeFrame: Up to Day 57
measure: Change From Baseline in Patient- Reported Outcome (PRO) Measures of Health-Related Quality of Life, as Assessed by the 36-item Short Form Version 2 (SF-36v2) Score at Days 8, 15, 28 and 42
timeFrame: Baseline, Days 8, 15, 28 and 42
measure: Change From Baseline in PRO Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Total Score at Days 8, 15, 28 and 42
timeFrame: Baseline, Days 8, 15, 28 and 42
Other outcomes:
Locations:
city: Rogers
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: Glendale
country: United States
facility: Sage Investigational Site
state: California
city: Lemon Grove
country: United States
facility: Sage Investigational Site
state: California
city: Orange
country: United States
facility: Sage Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Sage Investigational Site
state: California
city: Redlands
country: United States
facility: Sage Investigational Site
state: California
city: San Diego
country: United States
facility: Sage Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Sage Investigational Site
state: California
city: Temecula
country: United States
facility: Sage Investigational Site
state: California
city: Coral Springs
country: United States
facility: Sage Investigational Site
state: Florida
city: Hollywood
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: Orange City
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: 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: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Skokie
country: United States
facility: Sage Investigational Site
state: Illinois
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: O'Fallon
country: United States
facility: Sage Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Sage Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Sage Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
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: Portland
country: United States
facility: Sage Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Sage Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Sage Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Sage Investigational Site
state: Tennessee
city: DeSoto
country: United States
facility: Sage Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Sage Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Sage Investigational Site
state: Virginia
Study officials:
References: