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| ID | Type | Description | Link |
|---|---|---|---|
| 89495120MDD2001 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-89495120 | Drug | JNJ-89495120 will be administered. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Huntsville Regional Medical Campus | Huntsville | Alabama | 35801 | United States | ||
| Chandler Clinical Trials |
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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| Placebo | Drug | Placebo will be administered. |
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| 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 |
| 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 |
| 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 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| IMA Clinical Research PC Phoenix | Phoenix | Arizona | 85012 | United States |
| Noble Clinical Research | Tucson | Arizona | 85704 | United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| CI Trials | Bellflower | California | 90706 | United States |
| Wake Research PRI Encino | Encino | California | 91316 | United States |
| National Institute Of Clinical Research | Garden Grove | California | 92844 | United States |
| WR-Newport Beach | Newport Beach | California | 92660 | United States |
| ATP Clinical Research | Orange | California | 92866 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Lumos Clinical Research Center LLC | San Jose | California | 95124 | United States |
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States |
| Inland Psychiatric Medical Group Inc | Temecula | California | 92591 | United States |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | United States |
| Mountain View Clinical Research | Denver | Colorado | 80209 | United States |
| Gulfcoast Medical Research Center | Fort Myers | Florida | 33912 | United States |
| The Medici Medical Research | Hollywood | Florida | 33021 | United States |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | United States |
| K2 Medical Research | Maitland | Florida | 32751 | United States |
| Pharmax Research Clinic Inc | Miami | Florida | 33126 | United States |
| Wellness Research Center | Miami | Florida | 33135 | United States |
| Best Choice Medical and Research Service | Pembroke Pines | Florida | 33024 | United States |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | United States |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | United States |
| Synexus Clinical Research US Inc | Atlanta | Georgia | 30328 | United States |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | United States |
| Accelerated Clinical Research Group LLC | Snellville | Georgia | 30078 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University IU Health | Indianapolis | Indiana | 46202 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Integrative Clinical Trials LLC | Brooklyn | New York | 11229 | United States |
| Patient Priority Clinical Sites LLC | Cincinnati | Ohio | 45215 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| OSU Department of Psychiatry and Behavioral Health | Columbus | Ohio | 43210 | United States |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73116 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Revival Research Institute LLC | McKinney | Texas | 75071 | United States |
| Alpine Research Organization | Clinton | Utah | 84015 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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