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

Open to people ages 18-64

• 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.

• 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
• 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.