Clinical trial NCT03672175: A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
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: Major Depressive Disorder
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants 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 with symptoms that had been present for at least a 4-week period.
2. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant had active psychosis.
2. Participant had attempted suicide associated with the current episode of MDD.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Primary outcomes:
measure: Change From Baseline in the 17-item HAM-D Total Score at Day 15
timeFrame: Baseline (BL), Day 15
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in the 17-item HAM-D Total Score
timeFrame: Baseline, Days 3, 8, 42, and 182
measure: Number of Participants Achieving HAM-D Response
timeFrame: Days 15, 42, and 182
measure: Number of Participants Achieving HAM-D Remission
timeFrame: Days 15, 42, and 182
measure: Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15
timeFrame: Day 15
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15
timeFrame: Baseline, Day 15
measure: Change From Baseline in HAM-D Core Subscale Score
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in HAM-D Anxiety Subscale Score
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in HAM-D Bech-6 Subscale Score
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in HAM-D Maier Subscale Score
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in HAM-D Individual Item Scores
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in Insomnia Severity Index (ISI) Total Score
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST)
timeFrame: Baseline, Days 15, and 28
measure: Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW)
timeFrame: Baseline, Days 15, and 28
measure: Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response
timeFrame: Baseline, Days 15, and 28
measure: Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores
timeFrame: Baseline, Days 15, and 42
measure: Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score
timeFrame: Baseline, Days 15, and 42
measure: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods
timeFrame: Treatment period: Up to Day 14; FU period: Day 15 to 42
measure: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period
timeFrame: Extended FU Period: Day 43 to 182
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods
timeFrame: Treatment period: Up to Day 14; FU period: Day 15 to 42
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period
timeFrame: Extended FU Period: Day 43 to 182
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods
timeFrame: Treatment period: Up to Day 14; FU period: Day 15 to 42
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period
timeFrame: Extended FU Period: Day 43 to 182
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods
timeFrame: Treatment period: Up to Day 14; FU period: Day 15 to 42
measure: Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period
timeFrame: Extended FU Period: Day 43 to 182
measure: Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Double-blind Treatment Period at Day 42
timeFrame: Day 42
measure: Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Extended FU Period at Day 182
timeFrame: Day 182
measure: Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score
timeFrame: Baseline, Days 15, 18, and 21
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: National City
country: United States
facility: Sage Investigational Site
state: California
city: Oakland
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: 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: Maitland
country: United States
facility: Sage Investigational Site
state: Florida
city: North Miami
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: 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: Site Investigational Site
state: Georgia
city: Skokie
country: United States
facility: Sage Investigational Site
state: Illinois
city: Pikesville
country: United States
facility: Sage Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: O'Fallon
country: United States
facility: Sage Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Sage Investigational Site
state: Missouri
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: Jamaica
country: United States
facility: Sage Investigational Site
state: New York
city: Rochester
country: United States
facility: Sage Investigational Site
state: New York
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: Oklahoma City
country: United States
facility: Sage Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Sage Investigational Site
state: Oregon
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: Austin
country: United States
facility: Sage Investigational Site
state: Texas
city: Bellaire
country: United States
facility: Sage Investigational Site
state: Texas
city: DeSoto
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: Charlottesville
country: United States
facility: Sage Investigational Site
state: Virginia
Study officials:
References: