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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
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

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. Samuel Sanchez PSC /ID# 246047
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CaguasPuerto RicoUnknown status
GCM Medical Group PSC /ID# 246048
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San JuanPuerto RicoUnknown status
Advanced Research Center /ID# 241903
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AnaheimUnited StatesUnknown status
Atlanta Center for Medical Research /ID# 234698
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AtlantaUnited StatesUnknown status
BioBehavioral Research of Austin /ID# 236479
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AustinUnited StatesUnknown status
Quest Therapeutics of Avon Lake /ID# 235956
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Avon LakeUnited StatesUnknown status
Pillar Clinical Research /ID# 236434
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BentonvilleUnited StatesUnknown status
Erie County Medical Center /ID# 237204
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BuffaloUnited StatesUnknown status
Cincinnati Children's Hospital /ID# 251020
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CincinnatiUnited StatesUnknown status
University of Cincinnati /ID# 236913
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CincinnatiUnited StatesUnknown status
Cedar Health Research /ID# 259364
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DallasUnited StatesUnknown status
CenExcel iResearch LLC /ID# 237391
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DecaturUnited StatesUnknown status
D&H Doral Research Center-Doral /ID# 255459
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DoralUnited StatesUnknown status
Harmonex Neuroscience Research /ID# 234938
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DothanUnited StatesUnknown status
Atlanta Behavioral Research, LLC /ID# 236374
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DunwoodyUnited StatesUnknown status
Core Clinical Research /ID# 236409
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EverettUnited StatesUnknown status
Sarkis Clinical Trials /ID# 236893
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GainesvilleUnited StatesUnknown status
Galiz Research- Palmetto Medical Plaza /ID# 236277
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HialeahUnited StatesUnknown status
Ascension Illinois /ID# 235857
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Hoffman EstatesUnited StatesUnknown status
Advanced Research Institute of Miami /ID# 242505
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HomesteadUnited StatesUnknown status
Red Oak Psychiatry Associates /ID# 236602
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HoustonUnited StatesUnknown status
Med Clinical Research Partners LLC /ID# 236071
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IrvingtonUnited StatesUnknown status
New Dawn Psychiatric Services PLLC /ID# 236597
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KinstonUnited StatesUnknown status
Duplicate_Sandhill Research LLC /ID# 251239
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Lake MaryUnited StatesUnknown status
Duplicate_Alliance for Research - Long Beach /ID# 236261
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Long BeachUnited StatesUnknown status
Links Clinical Trials /ID# 240975
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MiamiUnited StatesUnknown status
Florida Research Center, Inc. /ID# 236515
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MiamiUnited StatesUnknown status
G+C Research Group, LLC /ID# 261398
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MiamiUnited StatesUnknown status
Columbus Clinical Services, Llc /Id# 234281
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MiamiUnited StatesUnknown status
South Florida Research Ph I-IV /ID# 237453
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Miami SpringsUnited StatesUnknown status
Cutting Edge Research Group /ID# 236664
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Oklahoma CityUnited StatesUnknown status
ATP Clinical Research- Orange /ID# 257095
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OrangeUnited StatesUnknown status
CHOC Children's Hospital /ID# 251019
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OrangeUnited StatesUnknown status
K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528
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OrlandoUnited StatesUnknown status
APG Research, LLC /ID# 251153
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OrlandoUnited StatesUnknown status
AIM Trials /ID# 236368
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PlanoUnited StatesUnknown status
Prospective Research Innovations Inc /ID# 236098
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Rancho CucamongaUnited StatesUnknown status
University of California, San Diego Department of Psychiatry /ID# 236466
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San DiegoUnited StatesUnknown status
D&H Tamarac Research Center /ID# 250435
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TamaracUnited StatesUnknown status
Family Psychiatry of The Woodlands /ID# 236426
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The WoodlandsUnited StatesUnknown status
Pacific Clinical Research Management Group /ID# 234377
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UplandUnited StatesUnknown status
CincyScience /ID# 236390
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West ChesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.