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NCT07573176PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

4/30/2026

Completion Date

5/3/2029

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 Criteria

Age Range: 18 years to 74 years

Inclusion criteria: * Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment * Experienced at least one MDD episode prior to their current episode * Current episode of MDD must be a minimum of 2 weeks in duration * Must meet one of the following criteria regarding current medication status. 1. Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document). OR 2. Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance. * Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) * Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) Exclusion criteria: * Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening) * Has treatment-resistant depression (TRD) * Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years * Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia * Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders * Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder * Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months * Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months * Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions * Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

Interventions

DRUG

Seltorexant

DRUG

Placebo

Interested in This Trial?

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Conditions

Depressive Disorder, Major

Locations

CI Trials

Bellflower, California 90706

United States

Behavioral Research Specialists LLC

Glendale, California 91206

United States

Excell Research Inc

Oceanside, California 92056

United States

NRC Research Institute

Orange, California 92868

United States

Cenexel

Riverside, California 92506

United States

Sunwise Clinical Research

Walnut Creek, California 94596

United States

UHC Research

Doral, Florida 33178

United States

Reliable Clinical Research

Hialeah, Florida 33012

United States

Nuovida Research Center

Miami, Florida 33186

United States

IPTB Clinical Research

Tampa, Florida 33629

United States

Health Synergy Clinical Research

West Palm Beach, Florida 33407

United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia 30328

United States

Accelerated Clinical Research Group LLC

Snellville, Georgia 30078

United States

Chicago Research Center

Chicago, Illinois 60634

United States

Adams Clinical Boston

Boston, Massachusetts 02116

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

CenExel Marlton NJ

Marlton, New Jersey 08053

United States

Integrative Clinical Trials LLC

Brooklyn, New York 11229

United States

Bioscience Research LLC

Mount Kisco, New York 10549

United States

Fieve Clinical Research Inc

New York, New York 10017

United States

Manhattan Behavioral Medicine

New York, New York 10036

United States

Patient Priority Clinical Sites LLC

Cincinnati, Ohio 45215

United States

Conrad Clinical Research

Edmond, Oklahoma 73013

United States

Sooner Clinical Research

Oklahoma City, Oklahoma 73116

United States

Alpine Research Organization

Clinton, Utah 84015

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Centro Integrado Facili

São Bernardo do Campo, 09726 150

Brazil

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Taipei Medical University Hospital

Taipei, 110

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan