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
NCT ID: NCT04578756
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
310 participants
INTERVENTIONAL
2021-02-01
2025-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cariprazine Dose 1
Participants with Schizophrenia (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 2
Participants with Schizophrenia (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 3
Participants with Bipolar I Disorder (age 10 to 12 years and \<40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 4
Participants with Bipolar I Disorder (age 10 to 12 years and \>= 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 5
Participants with Bipolar I Disorder (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 6
Participants with Bipolar I Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 7
Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.
Cariprazine Flexible Dose
Dose solution (in milliliters) to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 8
Participants with Autism Spectrum Disorder (age 10 to 12 years and \<40 kg weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 9
Participants with Autism Spectrum Disorder (age 10 to 12 years and \>=40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 10
Participants with Autism Spectrum Disorder (age 13 to 17 years and \<40 kg weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Dose 11
Participants with Autism Spectrum Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Interventions
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Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)
Cariprazine Flexible Dose
Dose solution (in milliliters) to be taken orally at approximately the same time of day (morning or evening)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Ascension Illinois /ID# 235857
Hoffman Estates, Illinois, United States
Med Clinical Research Partners LLC /ID# 236071
Irvington, New Jersey, United States
Erie County Medical Center /ID# 237204
Buffalo, New York, United States
New Dawn Psychiatric Services PLLC /ID# 236597
Kinston, North Carolina, United States
Quest Therapeutics of Avon Lake /ID# 235956
Avon Lake, Ohio, United States
University of Cincinnati /ID# 236913
Cincinnati, Ohio, United States
Cincinnati Children's Hospital /ID# 251020
Cincinnati, Ohio, United States
CincyScience /ID# 236390
West Chester, Ohio, United States
Cutting Edge Research Group /ID# 236664
Oklahoma City, Oklahoma, United States
BioBehavioral Research of Austin /ID# 236479
Austin, Texas, United States
Cedar Health Research /ID# 259364
Dallas, Texas, United States
Red Oak Psychiatry Associates /ID# 236602
Houston, Texas, United States
AIM Trials /ID# 236368
Plano, Texas, United States
Family Psychiatry of The Woodlands /ID# 236426
The Woodlands, Texas, United States
Core Clinical Research /ID# 236409
Everett, Washington, United States
Dr. Samuel Sanchez PSC /ID# 246047
Caguas, , Puerto Rico
GCM Medical Group PSC /ID# 246048
San Juan, , Puerto Rico
Countries
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Related Links
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Other Identifiers
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3070-301-001
Identifier Type: -
Identifier Source: org_study_id
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