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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509070-36-00

Acronym

42847922MDD3003

Enrollment

230

Registered

2025-03-03

Start date

2025-03-18

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder with Insomnia Symptoms

Brief summary

Part 1 (Efficacy): Change from baseline to Day 43 in the MADRS total score., Part 2 Time from randomization to the first relapse during the double-blind (DB) Maintenance Phase in participants who achieve a stable response at the end of open-label (OL) seltorexant treatment

Interventions

DRUGJNJ-42847922

DRUGPlacebo Film-coated tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 (Efficacy): Change from baseline to Day 43 in the MADRS total score., Part 2 Time from randomization to the first relapse during the double-blind (DB) Maintenance Phase in participants who achieve a stable response at the end of open-label (OL) seltorexant treatment	—

Countries

Bulgaria, Czechia, Italy, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026