A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder (Moonlight-1)

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo; Drug: JNJ-89495120

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Completed
      • UAB Huntsville Regional Medical Campus
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Completed
      • Chandler Clinical Trials
    • Phoenix, Arizona, United States, 85012
      • Completed
      • IMA Clinical Research PC Phoenix
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
    • Tucson, Arizona, United States, 85704
      • Completed
      • Noble Clinical Research
  • California
    • Bellflower, California, United States, 90706
      • Recruiting
      • CI Trials
    • Encino, California, United States, 91316
      • Completed
      • Wake Research PRI Encino
    • Garden Grove, California, United States, 92844
      • Completed
      • National Institute of Clinical Research
    • Newport Beach, California, United States, 92660
      • Completed
      • WR-Newport Beach
    • Orange, California, United States, 92866
      • Recruiting
      • ATP Clinical Research
    • Redlands, California, United States, 92374
      • Recruiting
      • Anderson Clinical Research
    • San Diego, California, United States, 92103
      • Completed
      • Artemis Institute for Clinical Research
    • San Jose, California, United States, 95124
      • Recruiting
      • Lumos Clinical Research Center LLC
    • Santa Ana, California, United States, 92705
      • Recruiting
      • Syrentis Clinical Research
    • Temecula, California, United States, 92591
      • Recruiting
      • Inland Psychiatric Medical Group Inc
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Sunwise Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Completed
      • Mountain View Clinical Research
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Completed
      • Gulfcoast Medical Research Center
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • The Medici Medical Research
    • Homestead, Florida, United States, 33030
      • Completed
      • Advanced Research Institute of Miami
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research
    • Miami, Florida, United States, 33126
      • Recruiting
      • Pharmax Research Clinic Inc
    • Miami, Florida, United States, 33135
      • Recruiting
      • Wellness Research Center
    • Pembroke Pines, Florida, United States, 33024
      • Completed
      • Best Choice Medical and Research Service
    • Tampa, Florida, United States, 33629
      • Recruiting
      • Interventional Psychiatry of Tampa Bay
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Health Synergy Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Synexus Clinical Research US Inc
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • iResearch Atlanta LLC
    • Snellville, Georgia, United States, 30078
      • Recruiting
      • Accelerated Clinical Research Group LLC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University IU Health
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Completed
      • DelRicht Research
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Completed
      • CBH Health
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Medical School
  • New York
    • Brooklyn, New York, United States, 11229
      • Recruiting
      • Integrative Clinical Trials LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Completed
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45215
      • Recruiting
      • Patient Priority Clinical Sites LLC
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • OSU Department of Psychiatry and Behavioral Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Recruiting
      • Paradigm Research Professionals, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Completed
      • Coastal Carolina Research Center
  • Texas
    • McKinney, Texas, United States, 75071
      • Recruiting
      • Revival Research Institute LLC
  • Utah
    • Clinton, Utah, United States, 84015
      • Recruiting
      • Alpine Research Organization
  • Washington
    • Everett, Washington, United States, 98201
      • Recruiting
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5	The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.	Baseline up to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in MADRS Total Score to Day 2	The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.	Baseline up to Day 2
Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5	The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher score indicating greater severity.	Baseline up to Day 2 and Day 5
Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5	The SMDDS is a 16-item patient reported outcome (PRO) measure. Each item is rated by the participant according to a 5-point Likert scale, where 0 denotes "Not at all" or "Never" and 4 denotes "Extremely" or "Always". Before summing the items to create a total score, item 11 and item 12 are combined into a single score by selecting the highest severity on either item. The total score is then created by summing the responses on the 15 items, which range from 0 to 60. Higher score indicates more severe depressive symptomatology.	Baseline up to Day 5
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scale Score to Day 5	The GAD-7 scale is a self-administered questionnaire designed to measure anxiety. GAD-7 has seven items, which measure frequency of various signs of GAD using a 4-point Likert scale (where, Not at all = 0, Several days = 1, More than half the days = 2, and Nearly every day = 3). The total score ranges from 0 to 21 with increasing scores indicative of greater severity of symptoms of anxiety. Severity of anxiety on the GAD-7 is rated as follows: none (0-4), mild (5-9), moderate (10-14) and severe (15-21).	Baseline up to Day 5
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.	Up to approximately 18 weeks
Number of Participants with Abnormalities in Vital Signs Parameters	Participants with abnormalities in vital signs (supine blood pressure, pulse/heart rate, respiratory rate, oral temperature) parameters will be reported.	Up to approximately 18 weeks
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities	Participants with 12-lead ECG abnormalities will be reported.	Up to approximately 18 weeks
Number of Participants With Abnormalities in Laboratory Parameters	Participants with abnormalities in clinical laboratory parameters (hematology and serum chemistry) will be reported.	Up to approximately 18 weeks
Number of Participants Reporting Changes in Weight/Body Mass Index (BMI)	Participants with changes in weight/BMI will be reported.	Up to approximately 18 weeks
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score	The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.	Up to approximately 18 weeks
Plasma Concentrations of JNJ-89495120	Plasma concentrations of JNJ-89495120 will be reported.	Pre-dose (0 hours), and Post-dose on Days 1, 5 and 13
Change from Baseline in Cognitive Functioning Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)	The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials.	From Baseline up to 4 weeks
Change from Baseline in Cognitive Functioning Measured by the Digit Symbol Substitution Test (DSST)	The DSST is recognized as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention. The DSST measures attention, working memory, sustained visual attention and psychomotor speed. Participants are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds.	From Baseline up to 4 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2024
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 89495120MDD2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No