Recruiting
Phase 3

JNJ-42847922

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07573176

Conditions

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Seltorexant

Placebo

Study Details

Brief 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.

Conditions

Depressive Disorder, Major

Study ID

NCT07573176

Start date

Apr 30, 2026

Status verified date

Aug, 2026

Completion date

May 3, 2029

Anticipated

Primary completion date

Aug 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Seltorexant

Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (up to 6 months).

placebo comparator: Placebo

Participants will receive matching placebo tablet orally once daily from Day 1 to Day 42 in double-blind treatment phase. Eligible participants who will enter the OL treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ EW visit (up to 6 months).

Interventions

Seltorexant

Seltorexant tablet will be administered orally.

Placebo

Placebo tablet will be administered orally.

Primary outcome measure

  • Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) [ Time Frame: Baseline up to Day 43 ]
  • Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) [ Time Frame: OL Baseline (Day 43) Up to 6 months ]
  • OL Treatment Phase: Number of Participants with Vital Signs Abnormalities [ Time Frame: OL Baseline (Day 43) Up to 6 months ]
  • OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: OL Baseline (Day 43) Up to 6 months ]
  • OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) [ Time Frame: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days) ]
  • OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG) [ Time Frame: OL Baseline (Day 43) up to 6 months ]
  • OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) [ Time Frame: Up to 6 months ]
  • OL Treatment Phase: Change from Baseline in the Body Weight [ Time Frame: OL Baseline (Day 43) up to 6 months ]
  • OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) [ Time Frame: OL Baseline (Day 43) up to 6 months ]
  • OL Treatment Phase: Change from Baseline in the Waist Circumference [ Time Frame: OL Baseline (Day 43) up to 6 months ]
  • OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters [ Time Frame: OL Baseline (Day 43) up to 6 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

SanRo Clinical Research Group LLC WCG Clinical Network

Recruiting

Bryant, Arkansas, United States, 72022

CI Trials

Recruiting

Bellflower, California, United States, 90706

Behavioral Research Specialists LLC

Recruiting

Glendale, California, United States, 91206

Excell Research Inc

Recruiting

Oceanside, California, United States, 92056

NRC Research Institute

Recruiting

Orange, California, United States, 92868

Cenexel

Recruiting

Riverside, California, United States, 92506

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

UHC Research

Recruiting

Doral, Florida, United States, 33178

Reliable Clinical Research

Recruiting

Hialeah, Florida, United States, 33012

Nuovida Research Center

Recruiting

Miami, Florida, United States, 33186

IPTB Clinical Research

Recruiting

Tampa, Florida, United States, 33629

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Agile Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328

Accelerated Clinical Research Group LLC

Recruiting

Snellville, Georgia, United States, 30078

Chicago Research Center

Recruiting

Chicago, Illinois, United States, 60634

Pharmasite Research, Inc.

Recruiting

Baltimore, Maryland, United States, 21208

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

CenExel Marlton NJ

Recruiting

Marlton, New Jersey, United States, 08053

Integrative Clinical Trials LLC

Recruiting

Brooklyn, New York, United States, 11229

SPRI Clinical Trials, LLC

Recruiting

Brooklyn, New York, United States, 11235

Bioscience Research LLC

Recruiting

Mount Kisco, New York, United States, 10549

Fieve Clinical Research Inc

Recruiting

New York, New York, United States, 10017

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Manhattan Behavioral Medicine

Recruiting

New York, New York, United States, 10036

Magnolia Clinical Research LLC

Recruiting

Cary, North Carolina, United States, 27511

Patient Priority Clinical Sites LLC

Recruiting

Cincinnati, Ohio, United States, 45215

Conrad Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73013

Sooner Clinical Research

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Medical Arts Research Health Group

Recruiting

North Vancouver, British Columbia, Canada, V7P2T4

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.