Clinical trial NCT03771664: A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Insomnia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 87
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: This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.

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 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.
2. Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
3. Participant had an Insomnia Severity Index (ISI) score greater than or equal to (\>=) 15 (moderate to severe insomnia).
4. Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

Exclusion Criteria:

1. Participant had attempted suicide associated within the current episode of MDD.
2. Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
3. Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
4. Participant had a medical history of seizures.
5. Participant had active psychosis per Investigator assessment.

Primary outcomes:
measure: Average Change From Baseline in Sleep Efficiency (SE) as Assessed by Polysomnogram (PSG) at Days 13 and 14
timeFrame: Baseline and Days 13, 14
Secondary outcomes:
measure: Change From Baseline in Wake After Sleep Onset (WASO) From Persistent Sleep Onset to Lights-on (Final Wake Time)
timeFrame: Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording
measure: Change From Baseline in Total Sleep Time (TST)
timeFrame: Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording
measure: Change From Baseline in Latency to Persistent Sleep (LPS)
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in Number of Awakenings (NAW)
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in Mean Duration of Awakenings
timeFrame: Baseline, Day 14: Overall duration (8 hours) and each 2-hour quarter duration (quarter 1: 0 to 2 hours, quarter 2: 2 to 4 hours, quarter 3: 4 to 6 hours, quarter 4: 6 to 8 hours) of PSG recording
measure: Change From Baseline in Duration of Stage N1, N2, N3, and REM Sleep (in Minutes)
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in Percentage of N1, N2, N3 Stages, and REM Sleep Duration
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in Latency to the First Period and Each Subsequent Period (Periods 2, 3, 4) of REM Sleep
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in REM Density
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in REM Activity (REMA)
timeFrame: Baseline and Day 14 (EODBT)
measure: Change From Baseline in Insomnia Severity Index (ISI) Score
timeFrame: Baseline and Day 15
measure: Change From Baseline in Consensus Sleep Diary - Core (CSD-C) Parameters
timeFrame: Baseline and Day 15
measure: Change From Baseline in CSD-C Parameter: Subjective Sleep Quality (sSQ)
timeFrame: Baseline and Day 15
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Scale
timeFrame: Baseline and Day 15
measure: Mean Score of the Clinical Global Impression - Improvement (CGI-I) Scale
timeFrame: Day 15
measure: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score
timeFrame: Baseline and Day 15
measure: Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Score
timeFrame: Baseline and Day 15
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of drug up to last follow-up visit (approximately 72 days)
measure: Number of Participants With Potentially Clinically Significant Vital Signs
timeFrame: Screening up to last follow-up visit (approximately 72 days)
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
timeFrame: Screening up to last follow-up visit (approximately 72 days)
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Screening up to last follow-up visit (approximately 72 days)
measure: Number of Participants With Suicidal Ideation and Suicidal Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Screening up to last follow-up visit (approximately 72 days)
measure: Change From Baseline in the Withdrawal Symptoms as Measured by the Physician Withdrawal Checklist (PWC-20) Total Score
timeFrame: Baseline, Days 18, 22, 28, 35 and 42
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Garden Grove
country: United States
facility: Sage Investigational Site
state: California
city: Oceanside
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: Fort Myers
country: United States
facility: Sage Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Sage Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Sage Investigational Site
state: Florida
city: North Miami
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: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Sage Investigational Site
state: Illinois
city: Lake Charles
country: United States
facility: Sage Investigational Site
state: Louisiana
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
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: Albuquerque
country: United States
facility: Sage Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Sage Investigational Site
state: New York
city: New York
country: United States
facility: Sage Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Sage Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Sage Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Sage Investigational Site
state: Oklahoma
city: Salem
country: United States
facility: Sage Investigational Site
state: Oregon
city: Charleston
country: United States
facility: Sage Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Sage Investigational Site
state: Texas
Study officials:
References: