NCT06785012 A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
| NCT ID | NCT06785012 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2026-06-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-12-26 with a primary completion date of 2026-06-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT06785012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06785012 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06785012 currently recruiting?
Yes, NCT06785012 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT06785012 trial being conducted?
This trial is being conducted at Huntsville, United States, Chandler, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06785012 clinical trial?
NCT06785012 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 100 participants.