Depressive Disorder, MajorPhase 2Moonlight-1NCT06785012
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
A Phase 2 study testing JNJ-89495120 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 44 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- JNJ-89495120
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 44 sitesUnited States
- Study dates
- 26 Dec 2024to 10 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Synexus Clinical Research US Inc
Atlanta, Georgia, 30328
CI Trials
Bellflower, California, 90706
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Chandler Clinical Trials
Chandler, Arizona, 85224
University of Chicago Medical Center
Chicago, Illinois, 60637
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215
University of Cincinnati
Cincinnati, Ohio, 45219
Alpine Research Organization
Clinton, Utah, 84015
OSU Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43210
iResearch Atlanta LLC
Decatur, Georgia, 30030
Mountain View Clinical Research
Denver, Colorado, 80209
Wake Research PRI Encino
Encino, California, 91316
Core Clinical Research
Everett, Washington, 98201
Gulfcoast Medical Research Center
Fort Myers, Florida, 33912
CBH Health
Gaithersburg, Maryland, 20877
National Institute Of Clinical Research
Garden Grove, California, 92844
The Medici Medical Research
Hollywood, Florida, 33021
Advanced Research Institute of Miami
Homestead, Florida, 33030
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, 35801
Indiana University IU Health
Indianapolis, Indiana, 46202
K2 Medical Research
Maitland, Florida, 32751
Revival Research Institute LLC
McKinney, Texas, 75071
Pharmax Research Clinic Inc
Miami, Florida, 33126
Wellness Research Center
Miami, Florida, 33135
DelRicht Research
New Orleans, Louisiana, 70115
WR-Newport Beach
Newport Beach, California, 92660
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73116
ATP Clinical Research
Orange, California, 92866
Best Choice Medical and Research Service
Pembroke Pines, Florida, 33024
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
IMA Clinical Research PC Phoenix
Phoenix, Arizona, 85012
Anderson Clinical Research
Redlands, California, 92374
Artemis Institute for Clinical Research
San Diego, California, 92103
Lumos Clinical Research Center LLC
San Jose, California, 95124
Syrentis Clinical Research
Santa Ana, California, 92705
Accelerated Clinical Research Group LLC
Snellville, Georgia, 30078
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
Inland Psychiatric Medical Group Inc
Temecula, California, 92591
Noble Clinical Research
Tucson, Arizona, 85704
University of Arizona
Tucson, Arizona, 85724
Sunwise Clinical Research
Walnut Creek, California, 94596
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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)
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
- Being tested
- JNJ-89495120, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-89495120Drug
JNJ-89495120 will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: JNJ-89495120 Dose A | Experimental | Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study. Receives: Drug: JNJ-89495120 |
| Arm 2: JNJ-89495120 Dose A and Dose B | Experimental | 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. Receives: Drug: JNJ-89495120 |
| Arm 3: Placebo Group | Placebo comparator | Participants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Day 5
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to approximately 18 weeks
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Participants with 12-lead ECG abnormalities will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 18 weeks
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.
Measured: 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.
Measured: From Baseline up to 4 weeks
Plasma Concentrations of JNJ-89495120
Plasma concentrations of JNJ-89495120 will be reported.
Measured: Pre-dose (0 hours), and Post-dose on Days 1, 5 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start26 Dec 2024
- Primary completion25 Jun 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785012
- Sponsor's protocol ID
- 89495120MDD2001
- Other IDs
- 89495120MDD2001
- Acronym
- Moonlight-1
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06785012
- Acronym / sponsor ID
- Moonlight-1 / 89495120MDD2001
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: JNJ-89495120 Dose A | Experimental | Drug: JNJ-89495120Participants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study. |
| Arm 2: JNJ-89495120 Dose A and Dose B | Experimental | Drug: JNJ-89495120Participants 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. |
| Arm 3: Placebo Group | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-89495120JNJ-89495120 will be administered. | Drug | Arm 1: JNJ-89495120 Dose A, Arm 2: JNJ-89495120 Dose A and Dose B |
| PlaceboPlacebo will be administered. | Drug | Arm 3: Placebo Group |
Primary outcome
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5
Time frame: Baseline up 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.
13 secondary outcomes
Change from Baseline in MADRS Total Score to Day 2
Time frame: Baseline up to Day 2
Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5
Time frame: Baseline up to Day 2 and Day 5
Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5
Time frame: Baseline up to Day 5
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Scale Score to Day 5
Time frame: Baseline up to Day 5
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 18 weeks
Number of Participants with Abnormalities in Vital Signs Parameters
Time frame: Up to approximately 18 weeks
Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to approximately 18 weeks
Number of Participants With Abnormalities in Laboratory Parameters
Time frame: Up to approximately 18 weeks
Number of Participants Reporting Changes in Weight/Body Mass Index (BMI)
Time frame: Up to approximately 18 weeks
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to approximately 18 weeks
Change from Baseline in Cognitive Functioning Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: From Baseline up to 4 weeks
Change from Baseline in Cognitive Functioning Measured by the Digit Symbol Substitution Test (DSST)
Time frame: From Baseline up to 4 weeks
Plasma Concentrations of JNJ-89495120
Time frame: Pre-dose (0 hours), and Post-dose on Days 1, 5 and 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-89495120 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5 (time frame: Baseline up to Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.