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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called JNJ-89495120 for people with major depressive disorder (MDD), a serious condition that affects mood and daily life. The study aims to see how effective this treatment is in reducing depression symptoms compared to a placebo, which is a non-active treatment. Researchers are looking for participants aged 18 to 75 who have experienced at least one previous episode of depression before the age of 55 and are currently in a depressive episode lasting 2 to 24 months. Participants should have a body mass index (BMI) between 18 and 35 and must not have certain other mental health conditions or previous treatments that could interfere with the study.

If you decide to join the trial, you will be closely monitored by healthcare professionals who will check how well the treatment works for you and how well you tolerate it. This means they will look at any changes in your mood and any side effects you might experience. It's important to know that this study is currently recruiting participants, so if you or someone you know fits the criteria and is interested, it could be a chance to help advance treatment options for depression.

Gender

ALL

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