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

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Depressive Disorder, Major

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 74 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Janssen Research & Development, LLC

Last updated on ClinicalTrials.gov

September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites