drugset / Trial / NCT07573176

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

NCT07573176

Phase 3 Recruiting 600 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-04-30
Primary completion
2028-08-24
Completion
2029-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Seltorexant Small molecule Oral