Summary:
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.
Qualified Participants May Receive:
Monetary compensation and study-related health care at no cost to the participant.