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A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

Recruiting
18-64 years
All
Phase 2

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Overview

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

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

Study details
    Depressive Disorder
    Major

NCT06785012

Janssen Research & Development, LLC

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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