A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment with

To assess the efficacy of seltorexant 20 mg as monotherapy compared with placebo in improving depressive symptoms in participants with MDDIS

Study phase: III

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Adults 18-74 diagnosed with MDD with a current episode with at least a 2 week duration

Primary disease category: Mental Health

This study is enrolling healthy volunteers.

Sponsor: Janssen

Protocol number: 42847922MDD3011

Projected enrollment dates: August 2026 to November 2027

Official study title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment with Seltorexant