Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Inclusion Criteria:

• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.

• Ability to follow study instructions, complete study assessment tools with minimalassistance and no alteration to the assessment tools, and likely to complete allrequired visits.

• Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.

• PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.

• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positivesymptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior;P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

• Currently meeting DSM-5 criteria for any of the following:

• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

• Bipolar I and II disorder

• Autism spectrum disorder, intellectual development disorder, delirium, major/minorneurocognitive disorder

• History of meeting DSM-5 criteria for substance-related disorders (excludingcaffeine-related and tobacco-related disorders) within the prior 3 months before Visit

• Prior participation in any clinical trials involving experimental or investigationaldrugs within 6 months before Visit 1 or planned during the study.

• Female patients who are pregnant, planning to become pregnant during the course of thestudy, or are currently lactating.