Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine

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.