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Evaluating JNJ-89495120 for treating 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)

PHASE2 · Janssen Research & Development, LLC · NCT06785012

This study is testing a new medication called JNJ-89495120 to see if it can help people with major depressive disorder feel better compared to a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorJanssen Research & Development, LLC (industry)
Locations44 sites (Huntsville, Alabama and 43 other locations)
Trial IDNCT06785012 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and tolerability of JNJ-89495120 compared to a placebo in reducing symptoms of major depressive disorder (MDD). Participants will be individuals diagnosed with recurrent MDD, and the study will involve monitoring their response to the treatment over a specified period. The study will include a range of participants who have experienced at least one previous episode of depression and are currently in an episode lasting between 2 to 24 months. The methodology will involve clinical assessments based on established diagnostic criteria.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with recurrent major depressive disorder who have had at least one previous episode and are currently experiencing a depressive episode.

Not a fit: Patients who have undergone specific advanced treatments for depression, such as electroconvulsive therapy or vagus nerve stimulation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from major depressive disorder.

How similar studies have performed: Other studies exploring novel antidepressants have shown promise, but the specific approach of JNJ-89495120 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Huntsville, Alabama and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Depressive Disorder, Major

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.