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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 25, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06559306). This is a study registration, not published results. Lead sponsor: Janssen Research & Development, LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 752 participants (ESTIMATED). Conditions: Depressive Disorder, Major. Interventions: DRUG: Seltorexant; DRUG: Placebo; DRUG: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Primary outcome measures: Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 , Baseline, Day 43; Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response , Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months). Brief summary: 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).