RecruitingPhase 3NCT07573176

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

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


Sponsor

Janssen Research & Development, LLC

Enrollment

600 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Seltorexant for people with depressive disorder, major. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 74 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSeltorexant

Seltorexant tablet will be administered orally.

DRUGPlacebo

Placebo tablet will be administered orally.


Locations(16)

CI Trials

Bellflower, California, United States

Excell Research Inc

Oceanside, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

UHC Research

Doral, Florida, United States

Nuovida Research Center

Miami, Florida, United States

IPTB Clinical Research

Tampa, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Accelerated Clinical Research Group LLC

Snellville, Georgia, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

CenExel Marlton NJ

Marlton, New Jersey, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

Alpine Research Organization

Clinton, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07573176


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