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

Launched by ABBVIE · Oct 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and tolerability of a medication called cariprazine in children and young adults who have schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD). The research aims to understand how well the medication works over an extended period and to weigh its benefits against potential risks. The trial is currently active, but they are not recruiting new participants at this time.

To be eligible for this study, participants should be aged between 18 and 26 years and must have a confirmed diagnosis of schizophrenia, bipolar I disorder, or ASD. It's important that they have a caregiver, like a parent, who can help monitor their safety and attend all study visits. Participants will undergo health checks to ensure they are suitable for the study, and specific mental health conditions or serious health issues may prevent someone from joining. Those who participate can expect regular visits to the clinic for check-ups and monitoring over the course of the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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, and ECGs at the completion visit of the parent studies.
• • 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.
• Exclusion Criteria:
• • 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.
• • 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.