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)
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
UAB Huntsville Regional Medical Campus
RECRUITING
Huntsville
Arizona
Chandler Clinical Trials
TERMINATED
Chandler
IMA Clinical Research PC
RECRUITING
Phoenix
Noble Clinical Research
SUSPENDED
Tucson
California
CI Trials
RECRUITING
Bellflower
Wake Research PRI Encino
RECRUITING
Encino
National Institute Of Clinical Research
SUSPENDED
Garden Grove
WR-Newport Beach
RECRUITING
Newport Beach
ATP Clinical Research
RECRUITING
Orange
Anderson Clinical Research
RECRUITING
Redlands
Artemis Institute for Clinical Research
COMPLETED
San Diego
Lumos Clinical Research Center LLC
RECRUITING
San Jose
Syrentis Clinical Research
RECRUITING
Santa Ana
Viking Clinical Research Ltd
RECRUITING
Temecula
Sunwise Clinical Research
RECRUITING
Walnut Creek
Colorado
Mountain View Clinical Research
COMPLETED
Denver
Florida
Gulfcoast Medical Research Center
SUSPENDED
Fort Myers
The Medici Medical Research
RECRUITING
Hollywood
Advanced Research Institute of Miami
SUSPENDED
Homestead
K2 Medical Research
RECRUITING
Maitland
Pharmax Research Clinic Inc
RECRUITING
Miami
Wellness Research Center
RECRUITING
Miami
Best Choice Medical and Research Service
COMPLETED
Pembroke Pines
Interventional Psychiatry of Tampa Bay
RECRUITING
Tampa
Georgia
Synexus Clinical Research US Inc
RECRUITING
Atlanta
iResearch Atlanta LLC
RECRUITING
Decatur
Indiana
Indiana University IU Health
RECRUITING
Indianapolis
Louisiana
DelRicht Research
RECRUITING
New Orleans
Massachusetts
University of Massachusetts Medical School
RECRUITING
Worcester
Maryland
CBH Health
RECRUITING
Gaithersburg
New York
Integrative Clinical Trials LLC
RECRUITING
Brooklyn
Ohio
Patient Priority Clinical Sites LLC
RECRUITING
Cincinnati
University of Cincinnati
RECRUITING
Cincinnati
OSU Department of Psychiatry and Behavioral Health
RECRUITING
Columbus
Oklahoma
Paradigm Research Professionals, LLC
RECRUITING
Oklahoma City
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Coastal Carolina Research Center
RECRUITING
North Charleston
Texas
Revival Research Institute LLC
RECRUITING
Sherman
Utah
Alpine Research Organization
RECRUITING
Clinton
Washington
Core Clinical Research
RECRUITING
Everett
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-12-26
Estimated Completion Date:2026-06-26
Participants
Target number of participants:124
Treatments
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.
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.
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.