Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGAticaprant
Participants will receive aticaprant during the double blind (DB) treatment phase.
DRUGPlacebo
Participants will receive placebo during the DB treatment phase.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \[MINI\] for psychotic disorders * The participant must be on a stable dose of only one atypical antipyschotic medication * Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening * At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit * If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase
Exclusion criteria
* Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode) * Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment) * Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire * Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES) * Has current homicidal ideation/intent, per the investigator's clinical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screen Pass Rate | Up to 28 days | Screening pass rate of participants will be reported. |
| Exploratory Assessment-Specific Completion Rate | Up to 126 days | Assessment specific completion rate of participants will be reported. |
| 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 | — |
| Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time | Up to 126 days | 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. |
| Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score | Up to 84 days | — |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed