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Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

StatusRecruiting
PhasePhase 3
Started2024-07-25
View on ClinicalTrials.gov ↗
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an 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 a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Amendment history 2 changes detected by DataLookout

2026-08-29
minor
Completion pushed: 2026-12-30 → 2027-04-15
2026-04-14
minor
Trial sites expanded: 200 → 205 locations
Trial Details
NCT Number NCT06559306
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Major
Enrollment 752 participants
Start Date 2024-07-25
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-28