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A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
RECRUITINGPhase 2Sponsored by Janssen Research & Development, LLC
Actively Recruiting
PhasePhase 2
SponsorJanssen Research & Development, LLC
Started2024-12-26
Est. completion2026-06-26
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted
Locations43 sites
View on ClinicalTrials.gov →
NCT06785012
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
Age: 18 Years – 64 YearsHealthy volunteers accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Conditions2
DepressionDepressive Disorder, Major
Locations43 sites
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, 35801
Chandler Clinical Trials
Chandler, Arizona, 85224
IMA Clinical Research PC
Phoenix, Arizona, 85012
Noble Clinical Research
Tucson, Arizona, 85704
University of Arizona
Tucson, Arizona, 85724
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 2
SponsorJanssen Research & Development, LLC
Started2024-12-26
Est. completion2026-06-26
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted
Locations43 sites
View on ClinicalTrials.gov →
NCT06785012