If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
Meets current DSM-5-TR criteria for schizophrenia.
Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
Has a BPRS total score ≥ 45 at screening and baseline.
Has a PANSS total score ≥ 70 at baseline.
Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.
Adherence to prescribed antipsychotic treatment.
Patient has provided written informed consent prior to participating in the study.
You may not be if
Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
History or current diagnosis of other psychiatric or behavioral disorders.
Known suicidal risk, or a suicide attempt within the past 2 years.
History of neuroleptic malignant syndrome or priapism.
Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.
