Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465).
De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit 1. Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, ocular assessments, and ECGs, of which the results enabled ongoing trial participation. As such, eligibility for participants enrolling from these parent studies need not be contingent on results of these tests but participants must be withdrawn if results of these tests meet withdrawal criteria.
Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.
You CAN'T join if...
Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder.
Prior DSM-5-TR diagnosis of intellectual disability (IQ < 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ < 25) for ASD participants.
The participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
University of California, San Diego Department of Psychiatry /ID# 236466accepting new patients San Diego California 92103-8229 United States
CHOC Children's Hospital /ID# 251019accepting new patients Orange California 92868-4203 United States