A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
NCT ID: NCT06785012
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2024-12-26
2026-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: JNJ-89495120 Dose A
Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.
JNJ-89495120
JNJ-89495120 will be administered.
Arm 2: JNJ-89495120 Dose A and Dose B
Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study.
JNJ-89495120
JNJ-89495120 will be administered.
Arm 3: Placebo Group
Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.
Placebo
Placebo will be administered.
Interventions
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JNJ-89495120
JNJ-89495120 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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 but not 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 Criteria
* Current or past DSM-5 diagnosis of bipolar disorder, psychotic disorders, borderline personality disorder, antisocial personality disorder, or current obsessive-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, with the exclusion of nicotine, caffeine, and mild cannabis use disorder, according to the MINI and Clinical Assessment
* Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients
18 Years
64 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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UAB Huntsville Regional Medical Campus
Huntsville, Alabama, United States
Chandler Clinical Trials
Chandler, Arizona, United States
IMA Clinical Research PC
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
CI Trials
Bellflower, California, United States
Wake Research PRI Encino
Encino, California, United States
National Institute Of Clinical Research
Garden Grove, California, United States
WR-Newport Beach
Newport Beach, California, United States
ATP Clinical Research
Orange, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Lumos Clinical Research Center LLC
San Jose, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Viking Clinical Research Ltd
Temecula, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Gulfcoast Medical Research Center
Fort Myers, Florida, United States
The Medici Medical Research
Hollywood, Florida, United States
Advanced Research Institute of Miami
Homestead, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
Wellness Research Center
Miami, Florida, United States
Best Choice Medical and Research Service
Pembroke Pines, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Synexus Clinical Research US Inc
Atlanta, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Indiana University IU Health
Indianapolis, Indiana, United States
DelRicht Research
New Orleans, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
OSU Department of Psychiatry and Behavioral Health
Columbus, Ohio, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Revival Research Institute LLC
Sherman, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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89495120MDD2001
Identifier Type: OTHER
Identifier Source: secondary_id
89495120MDD2001
Identifier Type: -
Identifier Source: org_study_id