NCT06785012CompletedPhase 2
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 15 Jan 2025
- Start date
- 26 Dec 2024
- Primary completion date
- 25 Jun 2026
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Depression
- NCT number
- NCT06785012
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 105
- From 26 Dec 2024 to the primary completion date, 25 Jun 2026
- 44 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Synexus Clinical Research US Inc Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| CI Trials Coordinator of this site? Confirm its status | Bellflower | United States | Unknown status |
| Integrative Clinical Trials, LLC Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Chandler Clinical Trials Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Patient Priority Clinical Sites LLC Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Alpine Research Organization Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| OSU Department of Psychiatry and Behavioral Health Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| iResearch Atlanta, LLC Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Mountain View Clinical Research Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Wake Research PRI Encino Coordinator of this site? Confirm its status | Encino | United States | Unknown status |
| Core Clinical Research Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Gulfcoast Medical Research Center Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| CBH Health Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| National Institute Of Clinical Research Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| The Medici Medical Research Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Advanced Research Institute of Miami Coordinator of this site? Confirm its status | Homestead | United States | Unknown status |
| UAB Huntsville Regional Medical Campus Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Indiana University / IU Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Wellness Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pharmax Research Clinic Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Delricht Research Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| WR-Newport Beach Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Coastal Carolina Research Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Paradigm Research Professionals, LLC Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| ATP Clinical Research Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Best Choice Medical and Research Service Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| IMA Clinical Research PC Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Anderson Clinical Research Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Lumos Clinical Research Center LLC Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Syrentis Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Accelerated Clinical Research Group LLC Coordinator of this site? Confirm its status | Snellville | United States | Unknown status |
| Interventional Psychiatry of Tampa Bay Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Inland Psychiatric Medical Group Inc Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Noble Clinical Research Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Sunwise Clinical Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Health Synergy Clinical Research Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| University of Massachusetts Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.