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The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Aticaprant | Experimental | Participants will receive aticaprant during the double blind (DB) treatment phase. |
|
| Arm B: Placebo | Placebo Comparator | Participants will receive placebo during the DB treatment phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aticaprant | Drug | Participants will receive aticaprant during the double blind (DB) treatment phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Screen Pass Rate | Screening pass rate of participants will be reported. | Up to 28 days |
| Exploratory Assessment-Specific Completion Rate | Assessment specific completion rate of participants will be reported. | Up to 126 days |
| Total Assessment Completion Rate | Up to 126 days | |
| Study Completion Rate | Up to 126 days | |
| Adverse Events (AEs) Including AEs of Special Interest (AESI) | Up to 126 days | |
| Number of Participants with Abnormalities in Vital Signs | Up to 126 days | |
| Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG) | Up to 84 days | |
| Number of Participants with Abnormalities in Laboratory Parameters | Up to 84 days | |
| Number of Participants Reporting Changes in Body Weight | Up to 84 days | |
| Number of Participants Reporting Changes in Body Mass Index (BMI) | Up to 84 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS Network | Recruiting | Garden Grove | California | 92845 | United States | |
| Synexus Clinical Research US Inc |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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 | Participants will receive placebo during the DB treatment phase. |
|
| Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time | The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors. | Up to 126 days |
| Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score | Up to 84 days |
| Recruiting |
| Atlanta |
| Georgia |
| 30328 |
| United States |
| Uptown Research Institute | Recruiting | Chicago | Illinois | 60640 | United States |
| Western Michigan University | Recruiting | Kalamazoo | Michigan | 49008 | United States |
| Neurobehavioral Research Inc | Recruiting | Cedarhurst | New York | 11516 | United States |
| Evolution Research Group | Recruiting | Staten Island | New York | 10314 | United States |
| Community Clinical Research, Inc. | Recruiting | Austin | Texas | 78754 | United States |
| Pillar Clinical Research, LLC | Recruiting | Richardson | Texas | 75080 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000590915 | Aticaprant |
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