RecruitingPhase 2NCT06785012

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

A Randomized, Double-blind, Multicenter, Placebo-controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-89495120 as Monotherapy in Adult Participants With Major Depressive Disorder (MDD)

Sponsor

Janssen Research & Development, LLC

Enrollment

124 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

Depressive Disorder, Major

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called JNJ-89495120 for people with major depressive disorder (MDD) — persistent, debilitating depression — who haven't gotten better with standard treatments. Researchers want to see if this new approach can lift depression when other methods have failed. **You may be eligible if...** - You have been diagnosed with recurrent major depressive disorder by a psychiatrist - You were first diagnosed with depression before age 55 - Your current depressive episode has lasted at least 2 months but no longer than 24 months - You have had at least one previous episode of depression - You have not fully responded to prior antidepressant treatments **You may NOT be eligible if...** - You have psychotic features with your depression - You have other primary psychiatric conditions - Your current episode is outside the required time window (too short or too long) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-89495120

JNJ-89495120 will be administered.

DRUGPlacebo

Placebo will be administered.

Locations(44)

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

IMA Clinical Research PC Phoenix

Phoenix, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

University of Arizona

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

Inland Psychiatric Medical Group Inc

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

Health Synergy Clinical Research

West Palm Beach, Florida, United States

Synexus Clinical Research US Inc

Atlanta, Georgia, United States

iResearch Atlanta LLC

Decatur, Georgia, United States

Accelerated Clinical Research Group LLC

Snellville, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, 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

McKinney, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Core Clinical Research

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06785012

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