The purpose of this study is to assess the efficacy of seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with an selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant as adjunctive therapy to an antidepressant in participants with major depressive disorder (MDD) in open-label treatment phase.
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Double-blind (DB) Treatment Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Timeframe: Baseline, Day 43
Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability
Timeframe: 1 year
OL Treatment Phase: Change From Baseline in Blood Pressure
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change From Baseline in Pulse Rate
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change From Baseline in Weight
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change From Baseline in Body Mass Index (BMI)
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change From Baseline in Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Physician Withdrawal Checklist (PWC-20) Scores
Timeframe: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)
OL Treatment Phase: Number of Participants with Laboratory Abnormalities
Timeframe: Up to 1 year
OL Treatment Phase: Change From Baseline in QTc Interval
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change from Baseline in Heart Rate (HR)
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change from Baseline in QRS Interval
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change from Baseline in PR Interval
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Change From Baseline in QT Interval
Timeframe: Baseline (Day 43), up to 1 year
OL Treatment Phase: Participant-reported Sexual Functioning Using Arizona Sexual Experiences Scale (ASEX) Score
Timeframe: Up to 1 year