Clinical Research Directory

Key Inclusion Criteria: * Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only). * Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 0-4. * Men and women aged 18-64 years (inclusive). * Body mass index (BMI) 18.5-35. * Able to sign an informed consent form. * Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only). Key Exclusion Criteria: * Subjects with schizophrenia with PANSS item scores of \> 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control. * Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders. * Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening. * History or current cardiovascular or cerebrovascular disease. * History of seizures or conditions that lower the seizure threshold. * Use of concomitant administration of strong or moderate CYP3A4 inhibitors. * Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated. * Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years. * Subjects with a history of orthostatic hypotension and/or syncope. * Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only). * Subjects with CGI-S score of 5-7. * Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia. * For cohort 3 only: Subjects treated with oral Clozapine.