Clareo Health | Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
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.
Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
Positive and Negative Syndrome Scale (PANSS) total score \>= 70 and \<= 120 at Visit 1 and Visit 2 (Day 1).
Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.
You may not be if
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 Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
