Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia

Prior treatment

• Patient has a history of meeting DSM-5 diagnosis for any substancerelated disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
• Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug's package insert)
• Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to Baseline (Visit 2).

Other illness

• Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
• Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.

• In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures
• Male or female patients must be 13 to <18 years of age at the time of obtaining the patient's informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.
• Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician
• PANSS total score ≤ 60 at Screening and Baseline
• Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline
• CGI-S score ≤ 4 at Screening and Baseline
• Patients must agree to sexual abstinence or to use a highly effective contraceptive method (see Section 16.1) during the study and for 10 weeks after the last dose of the IMP. Male patients must agree to refrain from donating sperm during this period. Women using systematically acting hormonal contraceptives should add a second barrier method (e.g. male condom, diaphragm or cervical cap)