Anxiety & Depression Association of America

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

Purpose

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).

Condition

Depressive Disorder, Major

Eligibility

Eligible Ages: Between 18 Years and 64 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm 1: JNJ-89495120 Dose A	Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.	Drug: JNJ-89495120 JNJ-89495120 will be administered.
Experimental Arm 2: JNJ-89495120 Dose A and Dose B	Participants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study.	Drug: JNJ-89495120 JNJ-89495120 will be administered.
Placebo Comparator Arm 3: Placebo Group	Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.	Drug: Placebo Placebo will be administered.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.