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A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia

Schizophrenia
Clinicaltrials.gov:
J&J ID:
#67953964SCH1001
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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

Note: The criteria listed here are only a general guide. To join any trial, you must first have a medical check by a qualified doctor or healthcare professional. They will decide if the trial is a good fit and safe for your health.
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