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

NCT06785012 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 89495120MDD2001
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 44

Brief 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).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5

  The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  Baseline up to Day 5

Secondary Outcomes (13)

• Change from Baseline in MADRS Total Score to Day 2

  Baseline up to Day 2

• Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5

  Baseline up to Day 2 and Day 5

• Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5

  Baseline up to Day 5

• Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scale Score to Day 5

  Baseline up to Day 5

• Number of Participants with Adverse Events (AEs)

  Up to approximately 18 weeks

Study Arms (3)

Arm 1: JNJ-89495120 Dose A

EXPERIMENTAL

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

Arm 2: JNJ-89495120 Dose A and Dose B

EXPERIMENTAL

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

Arm 3: Placebo Group

PLACEBO COMPARATOR

Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.

Drug: Placebo

Interventions

JNJ-89495120 DRUG

JNJ-89495120 will be administered.

Arm 1: JNJ-89495120 Dose A; Arm 2: JNJ-89495120 Dose A and Dose B

Placebo DRUG

Placebo will be administered.

Arm 3: Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known allergies, hypersensitivity, or intolerance to JNJ-89495120 or its excipients

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (44)

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, 35801, United States

Location

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

Location

IMA Clinical Research PC Phoenix

Phoenix, Arizona, 85012, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

CI Trials

Bellflower, California, 90706, United States

Location

Wake Research PRI Encino

Encino, California, 91316, United States

Location

National Institute Of Clinical Research

Garden Grove, California, 92844, United States

Location

WR-Newport Beach

Newport Beach, California, 92660, United States

Location

ATP Clinical Research

Orange, California, 92866, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Lumos Clinical Research Center LLC

San Jose, California, 95124, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Inland Psychiatric Medical Group Inc

Temecula, California, 92591, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Gulfcoast Medical Research Center

Fort Myers, Florida, 33912, United States

Location

The Medici Medical Research

Hollywood, Florida, 33021, United States

Location

Advanced Research Institute of Miami

Homestead, Florida, 33030, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

Wellness Research Center

Miami, Florida, 33135, United States

Location

Best Choice Medical and Research Service

Pembroke Pines, Florida, 33024, United States

Location

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

Location

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

Location

Synexus Clinical Research US Inc

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Accelerated Clinical Research Group LLC

Snellville, Georgia, 30078, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University IU Health

Indianapolis, Indiana, 46202, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

OSU Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43210, United States

Location

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, 73116, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Revival Research Institute LLC

McKinney, Texas, 75071, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: December 26, 2024
• Primary Completion: June 25, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (44)