A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Depression

Treatment

JNJ-89495120

Placebo

Clinical Study ID

NCT06785012
89495120MDD2001
89495120MDD2001
  • Ages 18-64
  • All Genders

Study Summary

The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary psychiatric diagnosis of recurrent major depressive disorder, withoutpsychotic features, based on clinical assessment using diagnostic and statisticalmanual of mental disorders (DSM)-5 criteria and confirmed with the miniinternational neuropsychiatric interview (MINI)

  • Participant had to have at least one previous major depressive disorder (MDD)episode prior to their current episode

  • Were first diagnosed with depression before the age of 55

  • Are in a current episode of depression: Episode length must be at least 2 months butnot longer than 24 months

  • Have taken 0, 1, or 2 treatments for depression in your current episode

  • Body mass index (BMI) within the range 18 to 35 kilograms per square meter (kg/m^2)at screening

Exclusion

Exclusion Criteria:

  • Treatment with vagus nerve stimulation (VNS), electroconvulsive therapy (ECT),transcranial magnetic stimulation (TMS), deep brain stimulation (DBS), orketamine/esketamine within the current or past major depressive episodes

  • Current or past DSM-5 diagnosis of bipolar disorder, psychotic disorders, borderlinepersonality disorder, antisocial personality disorder, or currentobsessive-compulsive disorder

  • Post-traumatic stress disorder within the past three years of screening

  • Dementia, any dementing disease, intellectual disability, or neurocognitive disorder

  • History of Alcohol and Substance use disorders within 6 months of screening, withthe exclusion of nicotine, caffeine, and mild cannabis use disorder, according tothe MINI and Clinical Assessment

  • Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: JNJ-89495120
Phase: 2
Study Start date:
December 26, 2024
Estimated Completion Date:
June 26, 2026

Connect with a study center

  • Chandler Clinical Trials

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • IMA Clinical Research PC

    Phoenix, Arizona 85012
    United States

    Active - Recruiting

  • CI Trials

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Wake Research PRI Encino

    Encino, California 91316
    United States

    Active - Recruiting

  • National Institute Of Clinical Research

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • WR-Newport Beach

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • Anderson Clinical Research

    Redlands, California 92374
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Active - Recruiting

  • Lumos Clinical Research Center LLC

    San Jose, California 95124
    United States

    Active - Recruiting

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Viking Clinical Research Ltd

    Temecula, California 92591
    United States

    Active - Recruiting

  • Sunwise Clinical Research

    Walnut Creek, California 94546
    United States

    Active - Recruiting

  • Mountain View Clinical Research

    Denver, Colorado 80209
    United States

    Active - Recruiting

  • Gulfcoast Medical Research Center

    Fort Myers, Florida 33912
    United States

    Suspended

  • The Medici Medical Research

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Advanced Research Institute of Miami

    Homestead, Florida 33030
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Wellness Research Center

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Best Choice Medical and Research Service

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida 33629
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • iResearch Atlanta LLC

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Active - Recruiting

  • Integrative Clinical Trials LLC

    Brooklyn, New York 11229
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Revival Research Institute LLC

    Sherman, Texas 75092
    United States

    Active - Recruiting

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.