Clinical Trial

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.
Protocol Amendment History 5 changes
notable Trial sites expanded: 16 -> 30 locations 2026-08-01
notable Trial sites expanded: 10 -> 16 locations 2026-07-07
notable Trial sites expanded: 5 -> 10 locations 2026-06-06
critical Recruitment opened 2026-05-09
notable Trial sites expanded: 0 -> 5 locations 2026-05-09
Trial Details
NCT Number NCT07573176
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Major
Enrollment 600 participants
Start Date 2026-04-30
Primary Completion 2028-08-24 (estimated)
Study Completion 2029-05-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-31