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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

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Synexus Clinical Research US Inc
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AtlantaUnited StatesUnknown status
CI Trials
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BellflowerUnited StatesUnknown status
Integrative Clinical Trials, LLC
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BrooklynUnited StatesUnknown status
Chandler Clinical Trials
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ChandlerUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
Patient Priority Clinical Sites LLC
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CincinnatiUnited StatesUnknown status
Alpine Research Organization
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ClintonUnited StatesUnknown status
OSU Department of Psychiatry and Behavioral Health
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ColumbusUnited StatesUnknown status
iResearch Atlanta, LLC
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DecaturUnited StatesUnknown status
Mountain View Clinical Research
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DenverUnited StatesUnknown status
Wake Research PRI Encino
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EncinoUnited StatesUnknown status
Core Clinical Research
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EverettUnited StatesUnknown status
Gulfcoast Medical Research Center
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Fort MyersUnited StatesUnknown status
CBH Health
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GaithersburgUnited StatesUnknown status
National Institute Of Clinical Research
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Garden GroveUnited StatesUnknown status
The Medici Medical Research
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HollywoodUnited StatesUnknown status
Advanced Research Institute of Miami
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HomesteadUnited StatesUnknown status
UAB Huntsville Regional Medical Campus
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HuntsvilleUnited StatesUnknown status
Indiana University / IU Health
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IndianapolisUnited StatesUnknown status
K2 Medical Research
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MaitlandUnited StatesUnknown status
Revival Research Institute, LLC
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McKinneyUnited StatesUnknown status
Wellness Research Center
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MiamiUnited StatesUnknown status
Pharmax Research Clinic Inc
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MiamiUnited StatesUnknown status
Delricht Research
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New OrleansUnited StatesUnknown status
WR-Newport Beach
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Newport BeachUnited StatesUnknown status
Coastal Carolina Research Center
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North CharlestonUnited StatesUnknown status
Paradigm Research Professionals, LLC
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Oklahoma CityUnited StatesUnknown status
ATP Clinical Research
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OrangeUnited StatesUnknown status
Best Choice Medical and Research Service
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Pembroke PinesUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
IMA Clinical Research PC Phoenix
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PhoenixUnited StatesUnknown status
Anderson Clinical Research
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RedlandsUnited StatesUnknown status
Artemis Institute for Clinical Research
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San DiegoUnited StatesUnknown status
Lumos Clinical Research Center LLC
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San JoseUnited StatesUnknown status
Syrentis Clinical Research
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Santa AnaUnited StatesUnknown status
Accelerated Clinical Research Group LLC
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SnellvilleUnited StatesUnknown status
Interventional Psychiatry of Tampa Bay
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TampaUnited StatesUnknown status
Inland Psychiatric Medical Group Inc
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TemeculaUnited StatesUnknown status
University of Arizona
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TucsonUnited StatesUnknown status
Noble Clinical Research
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TucsonUnited StatesUnknown status
Sunwise Clinical Research
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Walnut CreekUnited StatesUnknown status
Health Synergy Clinical Research
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West Palm BeachUnited StatesUnknown status
University of Massachusetts Medical School
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.