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
Public ClinicalTrials.gov record NCT04578756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04578756
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 310 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 5 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2021 (Actual)
- Primary completion
- Oct 6, 2025 (Actual)
- Completion
- Oct 6, 2025 (Actual)
- Last update posted
- Oct 27, 2025
2021 – 2025
United States locations
- U.S. sites
- 40
- U.S. states
- 13
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research /ID# 234938 | Dothan | Alabama | 36303 | — |
| Pillar Clinical Research /ID# 236434 | Bentonville | Arkansas | 72712 | — |
| Advanced Research Center /ID# 241903 | Anaheim | California | 92805 | — |
| Duplicate_Alliance for Research - Long Beach /ID# 236261 | Long Beach | California | 90807 | — |
| CHOC Children's Hospital /ID# 251019 | Orange | California | 92868-4203 | — |
| ATP Clinical Research- Orange /ID# 257095 | Orange | California | 92868 | — |
| Prospective Research Innovations Inc /ID# 236098 | Rancho Cucamonga | California | 91730 | — |
| University of California, San Diego Department of Psychiatry /ID# 236466 | San Diego | California | 92103-8229 | — |
| Pacific Clinical Research Management Group /ID# 234377 | Upland | California | 91786 | — |
| D&H Doral Research Center-Doral /ID# 255459 | Doral | Florida | 33122 | — |
| Sarkis Clinical Trials /ID# 236893 | Gainesville | Florida | 32607 | — |
| Galiz Research- Palmetto Medical Plaza /ID# 236277 | Hialeah | Florida | 33016 | — |
| Advanced Research Institute of Miami /ID# 242505 | Homestead | Florida | 33030-4613 | — |
| Duplicate_Sandhill Research LLC /ID# 251239 | Lake Mary | Florida | 32746 | — |
| Columbus Clinical Services, Llc /Id# 234281 | Miami | Florida | 33125 | — |
| G+C Research Group, LLC /ID# 261398 | Miami | Florida | 33126-2018 | — |
| Florida Research Center, Inc. /ID# 236515 | Miami | Florida | 33174 | — |
| Links Clinical Trials /ID# 240975 | Miami | Florida | 33176-3227 | — |
| South Florida Research Ph I-IV /ID# 237453 | Miami Springs | Florida | 33166-7225 | — |
| K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528 | Orlando | Florida | 32751 | — |
| APG Research, LLC /ID# 251153 | Orlando | Florida | 32803 | — |
| D&H Tamarac Research Center /ID# 250435 | Tamarac | Florida | 33321-2979 | — |
| Atlanta Center for Medical Research /ID# 234698 | Atlanta | Georgia | 30331 | — |
| CenExcel iResearch LLC /ID# 237391 | Decatur | Georgia | 30030 | — |
| Atlanta Behavioral Research, LLC /ID# 236374 | Dunwoody | Georgia | 30338 | — |
| Ascension Illinois /ID# 235857 | Hoffman Estates | Illinois | 60169 | — |
| Med Clinical Research Partners LLC /ID# 236071 | Irvington | New Jersey | 07111 | — |
| Erie County Medical Center /ID# 237204 | Buffalo | New York | 14215 | — |
| New Dawn Psychiatric Services PLLC /ID# 236597 | Kinston | North Carolina | 28501-1603 | — |
| Quest Therapeutics of Avon Lake /ID# 235956 | Avon Lake | Ohio | 44012 | — |
| University of Cincinnati /ID# 236913 | Cincinnati | Ohio | 45219 | — |
| Cincinnati Children's Hospital /ID# 251020 | Cincinnati | Ohio | 45229 | — |
| CincyScience /ID# 236390 | West Chester | Ohio | 45069 | — |
| Cutting Edge Research Group /ID# 236664 | Oklahoma City | Oklahoma | 73116-1423 | — |
| BioBehavioral Research of Austin /ID# 236479 | Austin | Texas | 78759 | — |
| Cedar Health Research /ID# 259364 | Dallas | Texas | 75251-2202 | — |
| Red Oak Psychiatry Associates /ID# 236602 | Houston | Texas | 77090-2641 | — |
| AIM Trials /ID# 236368 | Plano | Texas | 75093 | — |
| Family Psychiatry of The Woodlands /ID# 236426 | The Woodlands | Texas | 77381 | — |
| Core Clinical Research /ID# 236409 | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04578756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04578756 live on ClinicalTrials.gov.