Trials Today

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 4068590, Alabama 4829764 35801

IMA Clinical Research PC
Phoenix 5308655, Arizona 5551752 85012

University of Arizona
Tucson 5318313, Arizona 5551752 85724

CI Trials
Bellflower 5327422, California 5332921 90706

Wake Research PRI Encino
Encino 5346649, California 5332921 91316

WR-Newport Beach
Newport Beach 5376890, California 5332921 92660

ATP Clinical Research
Orange 5379513, California 5332921 92866

Anderson Clinical Research
Redlands 5386754, California 5332921 92374

Lumos Clinical Research Center LLC
San Jose 5392171, California 5332921 95124

Syrentis Clinical Research
Santa Ana 5392900, California 5332921 92705

Viking Clinical Research Ltd
Temecula 5401395, California 5332921 92591

Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596

The Medici Medical Research
Hollywood 4158928, Florida 4155751 33021

K2 Medical Research
Maitland 4163220, Florida 4155751 32751

Pharmax Research Clinic Inc
Miami 4164138, Florida 4155751 33126

Wellness Research Center
Miami 4164138, Florida 4155751 33135

Interventional Psychiatry of Tampa Bay
Tampa 4174757, Florida 4155751 33629

Synexus Clinical Research US Inc
Atlanta 4180439, Georgia 4197000 30328

iResearch Atlanta LLC
Decatur 4191124, Georgia 4197000 30030

Indiana University IU Health
Indianapolis 4259418, Indiana 4921868 46202

DelRicht Research
New Orleans 4335045, Louisiana 4331987 70115

CBH Health
Gaithersburg 4355843, Maryland 4361885 20877

University of Massachusetts Medical School
Worcester 4956184, Massachusetts 6254926 01655

Integrative Clinical Trials LLC
Brooklyn 5110302, New York 5128638 11229

Patient Priority Clinical Sites LLC
Cincinnati 4508722, Ohio 5165418 45215

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219

OSU Department of Psychiatry and Behavioral Health
Columbus 4509177, Ohio 5165418 43210

Paradigm Research Professionals, LLC
Oklahoma City 4544349, Oklahoma 4544379 73116

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

Revival Research Institute LLC
Sherman 4728328, Texas 4736286 75092

Alpine Research Organization
Clinton 5773001, Utah 5549030 84015

Core Clinical Research
Everett 5793933, Washington 5815135 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.