for people ages 5-17 (full criteria)
at San Diego, California and other locations
study started
estimated completion



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.

Official Title

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


Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD), Cariprazine, Autistic Disorder, Autism Spectrum Disorder, Pervasive Child Development Disorders, Cariprazine Flexible Dose


You can join if…

Open to people ages 5-17

  • 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enrolling from these parent studies need not be contingent on results of these tests but participants must be withdrawn if results of these tests meet withdrawal criteria.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# 236466 accepting new patients
    San Diego California 92103-8229 United States
  • CHOC Children's Hospital /ID# 251019 accepting new patients
    Orange California 92868-4203 United States


accepting new patients
Start Date
Completion Date
Related Info
Phase 3 research study
Study Type
Expecting 280 study participants
Last Updated