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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2026-06-26

Brief Summary

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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).

Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

JNJ-89495120

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

JNJ-89495120

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered.

Interventions

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JNJ-89495120

JNJ-89495120 will be administered.

Intervention Type DRUG

Placebo

Placebo will be administered.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Chandler Clinical Trials

Chandler, Arizona, United States

Site Status TERMINATED

IMA Clinical Research PC

Phoenix, Arizona, United States

Site Status RECRUITING

Noble Clinical Research

Tucson, Arizona, United States

Site Status SUSPENDED

CI Trials

Bellflower, California, United States

Site Status RECRUITING

Wake Research PRI Encino

Encino, California, United States

Site Status RECRUITING

National Institute Of Clinical Research

Garden Grove, California, United States

Site Status SUSPENDED

WR-Newport Beach

Newport Beach, California, United States

Site Status RECRUITING

ATP Clinical Research

Orange, California, United States

Site Status RECRUITING

Anderson Clinical Research

Redlands, California, United States

Site Status RECRUITING

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status COMPLETED

Lumos Clinical Research Center LLC

San Jose, California, United States

Site Status RECRUITING

Syrentis Clinical Research

Santa Ana, California, United States

Site Status RECRUITING

Viking Clinical Research Ltd

Temecula, California, United States

Site Status RECRUITING

Sunwise Clinical Research

Walnut Creek, California, United States

Site Status RECRUITING

Mountain View Clinical Research

Denver, Colorado, United States

Site Status COMPLETED

Gulfcoast Medical Research Center

Fort Myers, Florida, United States

Site Status COMPLETED

The Medici Medical Research

Hollywood, Florida, United States

Site Status RECRUITING

Advanced Research Institute of Miami

Homestead, Florida, United States

Site Status COMPLETED

K2 Medical Research

Maitland, Florida, United States

Site Status RECRUITING

Pharmax Research Clinic Inc

Miami, Florida, United States

Site Status RECRUITING

Wellness Research Center

Miami, Florida, United States

Site Status RECRUITING

Best Choice Medical and Research Service

Pembroke Pines, Florida, United States

Site Status COMPLETED

Interventional Psychiatry of Tampa Bay

Tampa, Florida, United States

Site Status RECRUITING

Synexus Clinical Research US Inc

Atlanta, Georgia, United States

Site Status RECRUITING

iResearch Atlanta LLC

Decatur, Georgia, United States

Site Status RECRUITING

Indiana University IU Health

Indianapolis, Indiana, United States

Site Status RECRUITING

DelRicht Research

New Orleans, Louisiana, United States

Site Status RECRUITING

CBH Health

Gaithersburg, Maryland, United States

Site Status RECRUITING

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status RECRUITING

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Site Status RECRUITING

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

OSU Department of Psychiatry and Behavioral Health

Columbus, Ohio, United States

Site Status RECRUITING

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Site Status RECRUITING

Revival Research Institute LLC

Sherman, Texas, United States

Site Status RECRUITING

Alpine Research Organization

Clinton, Utah, United States

Site Status RECRUITING

Core Clinical Research

Everett, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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89495120MDD2001

Identifier Type: OTHER

Identifier Source: secondary_id

89495120MDD2001

Identifier Type: -

Identifier Source: org_study_id