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: Active_not_recruiting
Location: See all (44) 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
Huntsville
Arizona
Chandler Clinical Trials
Chandler
IMA Clinical Research PC Phoenix
Phoenix
Noble Clinical Research
Tucson
University of Arizona
Tucson
California
CI Trials
Bellflower
Wake Research PRI Encino
Encino
National Institute Of Clinical Research
Garden Grove
WR-Newport Beach
Newport Beach
ATP Clinical Research
Orange
Anderson Clinical Research
Redlands
Artemis Institute for Clinical Research
San Diego
Lumos Clinical Research Center LLC
San Jose
Syrentis Clinical Research
Santa Ana
Inland Psychiatric Medical Group Inc
Temecula
Sunwise Clinical Research
Walnut Creek
Colorado
Mountain View Clinical Research
Denver
Florida
Gulfcoast Medical Research Center
Fort Myers
The Medici Medical Research
Hollywood
Advanced Research Institute of Miami
Homestead
K2 Medical Research
Maitland
Pharmax Research Clinic Inc
Miami
Wellness Research Center
Miami
Best Choice Medical and Research Service
Pembroke Pines
Interventional Psychiatry of Tampa Bay
Tampa
Health Synergy Clinical Research
West Palm Beach
Georgia
Synexus Clinical Research US Inc
Atlanta
iResearch Atlanta LLC
Decatur
Accelerated Clinical Research Group LLC
Snellville
Illinois
University of Chicago Medical Center
Chicago
Indiana
Indiana University IU Health
Indianapolis
Louisiana
DelRicht Research
New Orleans
Massachusetts
University of Massachusetts Medical School
Worcester
Maryland
CBH Health
Gaithersburg
New York
Integrative Clinical Trials LLC
Brooklyn
Ohio
Patient Priority Clinical Sites LLC
Cincinnati
University of Cincinnati
Cincinnati
OSU Department of Psychiatry and Behavioral Health
Columbus
Oklahoma
Paradigm Research Professionals, LLC
Oklahoma City
Pennsylvania
University of Pennsylvania
Philadelphia
South Carolina
Coastal Carolina Research Center
North Charleston
Texas
Revival Research Institute LLC
Mckinney
Utah
Alpine Research Organization
Clinton
Washington
Core Clinical Research
Everett
Time Frame
Start Date:2024-12-26
Completion Date:2026-06-26
Participants
Target number of participants:107
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.