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 minimal
assistance and no alteration to the assessment tools, and likely to complete all
required 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 positive
symptoms; 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/minor
neurocognitive disorder

- History of meeting DSM-5 criteria for substance-related disorders (excluding
caffeine-related and tobacco-related disorders) within the prior 3 months before Visit
1.

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

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