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RECRUITING

NCT07573176

PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-04-30

Completion Date

2029-05-03

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Depressive Disorder, Major

Interventions

DRUG

Seltorexant

Seltorexant tablet will be administered orally.

DRUG

Placebo

Placebo tablet will be administered orally.

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 and confirmed by the SCID-CT diagnosed with first depressive episode prior to age 55 * Experienced at least one MDD episode prior to their current episode based on clinician-confirmed MDD diagnosis/MDE and documented in source records * Current episode of MDD must be a minimum of 8 weeks in duration and maximum of 24 months duration * Must meet one of the following criteria regarding current medication status. 1. Can be presenting for a new episode of MDD with no adequate antidepressant treatment started in the current episode; 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. 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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response as defined by the Massachusetts general hospital antidepressant treatment response questionnaire (MGH-ATRQ) * Body Mass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

Locations (53)

SanRo Clinical Research Group LLC WCG Clinical Network

Bryant, Arkansas, United States

CI Trials

Bellflower, California, United States

Behavioral Research Specialists LLC

Glendale, California, United States

Excell Research Inc

Oceanside, California, United States

NRC Research Institute

Orange, California, United States

Cenexel

Riverside, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

UHC Research

Doral, Florida, United States

Reliable Clinical Research

Hialeah, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Pharmax Research Clinic Inc

Miami, 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

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Accelerated Clinical Research Group LLC

Snellville, Georgia, United States

Chicago Research Center

Chicago, Illinois, United States

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

Integrative Clinical Trials LLC

Brooklyn, Mississippi, United States

SPRI Clinical Trials, LLC

Brooklyn, Mississippi, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

CenExel Marlton NJ

Marlton, New Jersey, United States

Bioscience Research LLC

Mount Kisco, New York, United States

Fieve Clinical Research Inc

New York, New York, United States

Adams Clinical Harlem

New York, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

Magnolia Clinical Research LLC

Cary, North Carolina, United States

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

Conrad Clinical Research

Edmond, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Future Search Trials of Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

DM Clinical Research

Houston, Texas, United States

Sooner Clinical Research

Oklahoma, Texas, United States

R and H Clinical Research

Stafford, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Iternova Consultorios en Salud Mental

Córdoba, Argentina

Resolution

Mendoza, Argentina

Instituto Apice

Salvador, Brazil

Centro Integrado Facili

São Bernardo do Campo, Brazil

BR Trials

São Paulo, Brazil

Medical Arts Research Health Group

North Vancouver, British Columbia, Canada

Providence Care Hospital

Kingston, Ontario, Canada

Beijing Huilongguan Hospital

Beijing, China

Shanghai Mental Health Center

Shanghai, China

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Chung Shan Medical University Hospital

Taichung, Taiwan

Taipei Mackay Memorial Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)