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

Last updated: October 9, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Depression

Treatment

Placebo

JNJ-89495120

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: Placebo
Phase: 2
Study Start date:
December 26, 2024
Estimated Completion Date:
June 26, 2026

Connect with a study center

  • UAB Huntsville Regional Medical Campus

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • UAB Huntsville Regional Medical Campus

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Active - Recruiting

  • Chandler Clinical Trials

    Chandler, Arizona 85224
    United States

    Site Not Available

  • IMA Clinical Research PC

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Chandler Clinical Trials

    Chandler 5289282, Arizona 5551752 85224
    United States

    Terminated

  • IMA Clinical Research PC

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Active - Recruiting

  • Noble Clinical Research

    Tucson 5318313, Arizona 5551752 85704
    United States

    Suspended

  • CI Trials

    Bellflower, California 90706
    United States

    Site Not Available

  • ATP Clinical Research

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Wake Research PRI Encino

    Encino, California 91316
    United States

    Site Not Available

  • National Institute Of Clinical Research

    Garden Grove, California 92844
    United States

    Site Not Available

  • WR-Newport Beach

    Newport Beach, California 92660
    United States

    Site Not Available

  • ATP Clinical Research

    Orange, California 92866
    United States

    Site Not Available

  • Anderson Clinical Research

    Redlands, California 92374
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Lumos Clinical Research Center LLC

    San Jose, California 95124
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Viking Clinical Research Ltd

    Temecula, California 92591
    United States

    Site Not Available

  • Sunwise Clinical Research

    Walnut Creek, California 94546
    United States

    Site Not Available

  • CI Trials

    Bellflower 5327422, California 5332921 90706
    United States

    Active - Recruiting

  • Wake Research PRI Encino

    Encino 5346649, California 5332921 91316
    United States

    Active - Recruiting

  • National Institute Of Clinical Research

    Garden Grove 5351515, California 5332921 92844
    United States

    Suspended

  • WR-Newport Beach

    Newport Beach 5376890, California 5332921 92660
    United States

    Active - Recruiting

  • ATP Clinical Research

    Orange 5379513, California 5332921 92866
    United States

    Active - Recruiting

  • Anderson Clinical Research

    Redlands 5386754, California 5332921 92374
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego 5391811, California 5332921 92103
    United States

    Completed

  • Lumos Clinical Research Center LLC

    San Jose 5392171, California 5332921 95124
    United States

    Active - Recruiting

  • Syrentis Clinical Research

    Santa Ana 5392900, California 5332921 92705
    United States

    Active - Recruiting

  • Viking Clinical Research Ltd

    Temecula 5401395, California 5332921 92591
    United States

    Active - Recruiting

  • Sunwise Clinical Research

    Walnut Creek 5406990, California 5332921 94546
    United States

    Active - Recruiting

  • Mountain View Clinical Research

    Denver, Colorado 80209
    United States

    Site Not Available

  • Mountain View Clinical Research

    Denver 5419384, Colorado 5417618 80209
    United States

    Completed

  • Gulfcoast Medical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • The Medici Medical Research

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Advanced Research Institute of Miami

    Homestead, Florida 33033
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • Pharmax Research Clinic Inc

    Miami, Florida 33126
    United States

    Site Not Available

  • Wellness Research Center

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Best Choice Medical and Research Service

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida 33629
    United States

    Site Not Available

  • Gulfcoast Medical Research Center

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Suspended

  • The Medici Medical Research

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Advanced Research Institute of Miami

    Homestead 4159050, Florida 4155751 33030
    United States

    Suspended

  • K2 Medical Research

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • Pharmax Research Clinic Inc

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Wellness Research Center

    Miami 4164138, Florida 4155751 33135
    United States

    Active - Recruiting

  • Best Choice Medical and Research Service

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Completed

  • Interventional Psychiatry of Tampa Bay

    Tampa 4174757, Florida 4155751 33629
    United States

    Active - Recruiting

  • Synexus Clinical Research US Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • iResearch Atlanta LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Active - Recruiting

  • iResearch Atlanta LLC

    Decatur 4191124, Georgia 4197000 30030
    United States

    Active - Recruiting

  • Indiana University IU Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University IU Health

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • DelRicht Research

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Active - Recruiting

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • CBH Health

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Active - Recruiting

  • University of Massachusetts Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Active - Recruiting

  • Integrative Clinical Trials LLC

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Integrative Clinical Trials LLC

    Brooklyn 5110302, New York 5128638 11229
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • OSU Department of Psychiatry and Behavioral Health

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Patient Priority Clinical Sites LLC

    Cincinnati 4508722, Ohio 5165418 45215
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • OSU Department of Psychiatry and Behavioral Health

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Paradigm Research Professionals, LLC

    Oklahoma City 4544349, Oklahoma 4544379 73116
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Active - Recruiting

  • Revival Research Institute LLC

    Sherman, Texas 75092
    United States

    Site Not Available

  • Revival Research Institute LLC

    Sherman 4728328, Texas 4736286 75092
    United States

    Active - Recruiting

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Site Not Available

  • Alpine Research Organization

    Clinton 5773001, Utah 5549030 84015
    United States

    Active - Recruiting

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Core Clinical Research

    Everett 5793933, Washington 5815135 98201
    United States

    Active - Recruiting

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