A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Depressive Disorder, Major
In brief
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).
Key facts
- Study ID
- NCT06785012
- Run by
- Janssen Research & Development, LLC
- People needed
- 107
- Starts
- 2024-12-26
- Expected to finish
- 2026-08-10
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UAB Huntsville Regional Medical Campus — Huntsville, Alabama, United States
- Chandler Clinical Trials — Chandler, Arizona, United States
- IMA Clinical Research PC Phoenix — Phoenix, Arizona, United States
- Noble Clinical Research — Tucson, Arizona, United States
- University of Arizona — Tucson, Arizona, United States
- CI Trials — Bellflower, California, United States
- Wake Research PRI Encino — Encino, California, United States
- National Institute Of Clinical Research — Garden Grove, California, United States
- WR-Newport Beach — Newport Beach, California, United States
- ATP Clinical Research — Orange, California, United States
- Anderson Clinical Research — Redlands, California, United States
- Artemis Institute for Clinical Research — San Diego, California, United States
- Lumos Clinical Research Center LLC — San Jose, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- Inland Psychiatric Medical Group Inc — Temecula, California, United States
- Sunwise Clinical Research — Walnut Creek, California, United States
- Mountain View Clinical Research — Denver, Colorado, United States
- Gulfcoast Medical Research Center — Fort Myers, Florida, United States
- The Medici Medical Research — Hollywood, Florida, United States
- Advanced Research Institute of Miami — Homestead, Florida, United States
- K2 Medical Research — Maitland, Florida, United States
- Pharmax Research Clinic Inc — Miami, Florida, United States
- Wellness Research Center — Miami, Florida, United States
- Best Choice Medical and Research Service — Pembroke Pines, Florida, United States
- Interventional Psychiatry of Tampa Bay — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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