Clinical Trial 43371

Garden Grove, CA 92845


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. 

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.