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

Description

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).

Conditions

Depressive Disorder, Major

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Study Overview

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Study Details

Study 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).

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)

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

Condition
Depressive Disorder, Major
Intervention / Treatment

-

Contacts and Locations

Redlands

Anderson Clinical Research, Redlands, California, United States, 92374

Temecula

Viking Clinical Research Ltd, Temecula, California, United States, 92591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-06-26