RecruitingPhase 2NCT06785012
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of 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)
Sponsor
Janssen Research & Development, LLC
Enrollment
124 participants
Start Date
Dec 26, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 64 Years
Inclusion Criteria6
- 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 Criteria6
- 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
Interventions
DRUGJNJ-89495120
JNJ-89495120 will be administered.
DRUGPlacebo
Placebo will be administered.
Locations(43)
View Full Details on ClinicalTrials.gov
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NCT06785012
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