NCT04578756CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 310 (actual)
- First submitted
- 1 Oct 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 6 Oct 2025
- Lead sponsor
- AbbVie
- Diseases
- Schizophrenia, Bipolar disorder, Autism
- NCT number
- NCT04578756
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 310
- From 1 Feb 2021 to the primary completion date, 6 Oct 2025
- 42 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Samuel Sanchez PSC /ID# 246047 Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| GCM Medical Group PSC /ID# 246048 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Advanced Research Center /ID# 241903 Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Atlanta Center for Medical Research /ID# 234698 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| BioBehavioral Research of Austin /ID# 236479 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Quest Therapeutics of Avon Lake /ID# 235956 Coordinator of this site? Confirm its status | Avon Lake | United States | Unknown status |
| Pillar Clinical Research /ID# 236434 Coordinator of this site? Confirm its status | Bentonville | United States | Unknown status |
| Erie County Medical Center /ID# 237204 Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Cincinnati Children's Hospital /ID# 251020 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Cincinnati /ID# 236913 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cedar Health Research /ID# 259364 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| CenExcel iResearch LLC /ID# 237391 Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| D&H Doral Research Center-Doral /ID# 255459 Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Harmonex Neuroscience Research /ID# 234938 Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Atlanta Behavioral Research, LLC /ID# 236374 Coordinator of this site? Confirm its status | Dunwoody | United States | Unknown status |
| Core Clinical Research /ID# 236409 Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Sarkis Clinical Trials /ID# 236893 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Galiz Research- Palmetto Medical Plaza /ID# 236277 Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Ascension Illinois /ID# 235857 Coordinator of this site? Confirm its status | Hoffman Estates | United States | Unknown status |
| Advanced Research Institute of Miami /ID# 242505 Coordinator of this site? Confirm its status | Homestead | United States | Unknown status |
| Red Oak Psychiatry Associates /ID# 236602 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Med Clinical Research Partners LLC /ID# 236071 Coordinator of this site? Confirm its status | Irvington | United States | Unknown status |
| New Dawn Psychiatric Services PLLC /ID# 236597 Coordinator of this site? Confirm its status | Kinston | United States | Unknown status |
| Duplicate_Sandhill Research LLC /ID# 251239 Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| Duplicate_Alliance for Research - Long Beach /ID# 236261 Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Links Clinical Trials /ID# 240975 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Florida Research Center, Inc. /ID# 236515 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| G+C Research Group, LLC /ID# 261398 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Columbus Clinical Services, Llc /Id# 234281 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| South Florida Research Ph I-IV /ID# 237453 Coordinator of this site? Confirm its status | Miami Springs | United States | Unknown status |
| Cutting Edge Research Group /ID# 236664 Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| ATP Clinical Research- Orange /ID# 257095 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| CHOC Children's Hospital /ID# 251019 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| APG Research, LLC /ID# 251153 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AIM Trials /ID# 236368 Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Prospective Research Innovations Inc /ID# 236098 Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Unknown status |
| University of California, San Diego Department of Psychiatry /ID# 236466 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| D&H Tamarac Research Center /ID# 250435 Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| Family Psychiatry of The Woodlands /ID# 236426 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Pacific Clinical Research Management Group /ID# 234377 Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| CincyScience /ID# 236390 Coordinator of this site? Confirm its status | West Chester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.