Condition: Schizophrenia · Sponsor: Janssen Research & Development, LLC
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CNS Network | Garden Grove, California, United States | Recruiting |
| Synexus Clinical Research US Inc | Atlanta, Georgia, United States | Recruiting |
| Uptown Research Institute | Chicago, Illinois, United States | Recruiting |
| Western Michigan University | Kalamazoo, Michigan, United States | Recruiting |
| Neurobehavioral Research Inc | Cedarhurst, New York, United States | Recruiting |
| Evolution Research Group | Staten Island, New York, United States | Recruiting |
| Community Clinical Research, Inc. | Austin, Texas, United States | Recruiting |
| Pillar Clinical Research, LLC | Richardson, Texas, United States | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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