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

Completed · Phase 3

Conditions studied: Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)

In brief

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.

Key facts

Study ID

NCT04578756

Run by

AbbVie

People needed

310

Starts

2021-02-01

Expected to finish

2025-10-06

Last updated by the study team

2025-10-27

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify 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.
• 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.

Where it is running

• Harmonex Neuroscience Research /ID# 234938 — Dothan, Alabama, United States
• Pillar Clinical Research /ID# 236434 — Bentonville, Arkansas, United States
• Advanced Research Center /ID# 241903 — Anaheim, California, United States
• Duplicate_Alliance for Research - Long Beach /ID# 236261 — Long Beach, California, United States
• CHOC Children's Hospital /ID# 251019 — Orange, California, United States
• ATP Clinical Research- Orange /ID# 257095 — Orange, California, United States
• Prospective Research Innovations Inc /ID# 236098 — Rancho Cucamonga, California, United States
• University of California, San Diego Department of Psychiatry /ID# 236466 — San Diego, California, United States
• Pacific Clinical Research Management Group /ID# 234377 — Upland, California, United States
• D&H Doral Research Center-Doral /ID# 255459 — Doral, Florida, United States
• Sarkis Clinical Trials /ID# 236893 — Gainesville, Florida, United States
• Galiz Research- Palmetto Medical Plaza /ID# 236277 — Hialeah, Florida, United States
• Advanced Research Institute of Miami /ID# 242505 — Homestead, Florida, United States
• Duplicate_Sandhill Research LLC /ID# 251239 — Lake Mary, Florida, United States
• Columbus Clinical Services, Llc /Id# 234281 — Miami, Florida, United States
• G+C Research Group, LLC /ID# 261398 — Miami, Florida, United States
• Florida Research Center, Inc. /ID# 236515 — Miami, Florida, United States
• Links Clinical Trials /ID# 240975 — Miami, Florida, United States
• South Florida Research Ph I-IV /ID# 237453 — Miami Springs, Florida, United States
• K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528 — Orlando, Florida, United States
• APG Research, LLC /ID# 251153 — Orlando, Florida, United States
• D&H Tamarac Research Center /ID# 250435 — Tamarac, Florida, United States
• Atlanta Center for Medical Research /ID# 234698 — Atlanta, Georgia, United States
• CenExcel iResearch LLC /ID# 237391 — Decatur, Georgia, United States
• Atlanta Behavioral Research, LLC /ID# 236374 — Dunwoody, Georgia, United States

Full record on ClinicalTrials.gov

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