NCT06559306

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

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Seltorexant	Seltorexant will be administered orally.
DRUG	Placebo	Matching Placebo tablets will be administered orally.
DRUG	Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)	SSRI/SNRI will be administered orally.

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-08-19
• Last updated: 2026-04-13

Locations

205 sites across 16 countries: United States, Argentina, Brazil, Bulgaria, Colombia, Czechia, Italy, Mexico, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study