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

Purpose

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).

Condition

Depressive Disorder, Major

Eligibility

Eligible Ages: Between 18 Years and 64 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Primary psychiatric diagnosis of recurrent major depressive disorder, without psychotic features, based on clinical assessment using diagnostic and statistical manual of mental disorders (DSM)-5 criteria and confirmed with the mini international 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 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

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 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.	Drug: JNJ-89495120 JNJ-89495120 will be administered.
Experimental 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.	Drug: JNJ-89495120 JNJ-89495120 will be administered.
Placebo Comparator 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.	Drug: Placebo Placebo will be administered.

Recruiting Locations

UAB Huntsville Regional Medical Campus
Huntsville, Alabama 35801

Chandler Clinical Trials
Chandler, Arizona 85224

IMA Clinical Research PC
Phoenix, Arizona 85012

Noble Clinical Research
Tucson, Arizona 85704

CI Trials
Bellflower, California 90706

ATP Clinical Research
Costa Mesa, California 92626

Wake Research PRI Encino
Encino, California 91316

National Institute Of Clinical Research
Garden Grove, California 92844

WR-Newport Beach
Newport Beach, California 92660

Anderson Clinical Research
Redlands, California 92374

Artemis Institute for Clinical Research
San Diego, California 92103

Lumos Clinical Research Center LLC
San Jose, California 95124

Syrentis Clinical Research
Santa Ana, California 92705

Viking Clinical Research Ltd
Temecula, California 92591

Sunwise Clinical Research
Walnut Creek, California 94546

Mountain View Clinical Research
Denver, Colorado 80209

The Medici Medical Research
Hollywood, Florida 33021

K2 Medical Research
Maitland, Florida 32751

Pharmax Research Clinic Inc
Miami, Florida 33126

Wellness Research Center
Miami, Florida 33135

Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629

Synexus Clinical Research US Inc
Atlanta, Georgia 30328

iResearch Atlanta LLC
Decatur, Georgia 30030

Indiana University IU Health
Indianapolis, Indiana 46202

DelRicht Research
New Orleans, Louisiana 70115

CBH Health
Gaithersburg, Maryland 20877

Integrative Clinical Trials LLC
Brooklyn, New York 11229

University of Cincinnati
Cincinnati, Ohio 45219

OSU Department of Psychiatry and Behavioral Health
Columbus, Ohio 43210

Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma 73116

Coastal Carolina Research Center
North Charleston, South Carolina 29405

Revival Research Institute LLC
Sherman, Texas 75092

Alpine Research Organization
Clinton, Utah 84015

Core Clinical Research
Everett, Washington 98201

More Details

NCT ID: NCT06785012
Status: Recruiting
Sponsor: Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.