Clinical trial NCT06785012: A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5
timeFrame: Baseline up to Day 5
Secondary outcomes:
measure: Change from Baseline in MADRS Total Score to Day 2
timeFrame: Baseline up to Day 2
measure: Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5
timeFrame: Baseline up to Day 2 and Day 5
measure: Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5
timeFrame: Baseline up to Day 5
measure: Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scale Score to Day 5
timeFrame: Baseline up to Day 5
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 18 weeks
measure: Number of Participants with Abnormalities in Vital Signs Parameters
timeFrame: Up to approximately 18 weeks
measure: Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: Up to approximately 18 weeks
measure: Number of Participants With Abnormalities in Laboratory Parameters
timeFrame: Up to approximately 18 weeks
measure: Number of Participants Reporting Changes in Weight/Body Mass Index (BMI)
timeFrame: Up to approximately 18 weeks
measure: Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to approximately 18 weeks
measure: Change from Baseline in Cognitive Functioning Measured by the Cogstate Test Battery
timeFrame: From Baseline up to 18 weeks
measure: Change from Baseline in Cognitive Functioning Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: From Baseline up to 18 weeks
measure: Change from Baseline in Cognitive Functioning Measured by the Digit Symbol Substitution Test (DSST)
timeFrame: From Baseline up to 18 weeks
measure: Plasma Concentrations of JNJ-89495120
timeFrame: Pre-dose (0 hours), and Post-dose on Days 1, 5 and 13
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Phoenix
country: United States
facility: IMA Clinical Research PC
state: Arizona
city: Bellflower
country: United States
facility: CI Trials
state: California
city: Encino
country: United States
facility: Wake Research PRI Encino
state: California
city: Garden Grove
country: United States
facility: National Institute Of Clinical Research
state: California
city: Newport Beach
country: United States
facility: WR-Newport Beach
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center LLC
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Ltd
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Fort Myers
country: United States
facility: Gulfcoast Medical Research Center
state: Florida
city: Hollywood
country: United States
facility: The Medici Medical Research
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Miami
country: United States
facility: Wellness Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: Best Choice Medical and Research Service
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US Inc
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Sherman
country: United States
facility: Revival Research Institute LLC
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: