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

Last updated: October 23, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Asperger's Disorder

Autism

Williams Syndrome

Treatment

Cariprazine Flexible Dose

Clinical Study ID

NCT04578756
3070-301-001
  • Ages 5-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with Diagnostic and Statistical Manual of Mental Disorders, FifthEdition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar Idisorder, or autism spectrum disorder as confirmed by Kiddie Schedule for AffectiveDisorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previouslyconfirmed in parent study for subjects who completed Study 3112-301-001 or M21-465).

  • De novo participants must have normal physical examination findings, clinicallaboratory test results, and electrocardiogram (ECG) results at Screening Visit 1.Abnormal results must not be clinically significant as determined by theinvestigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, andECGs at the completion visit of the parent studies.

  • Participant must have a caregiver (parent or legally authorized representative) whois willing and able to be responsible for safety monitoring of the participant,provide information about the participant's condition, oversee administration ofstudy intervention, and accompany the participant to all study visits.

Exclusion

Exclusion Criteria:

  • Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffectivedisorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorderdue to another medical condition. Participants with ASD that is associated with Rettdisorder, fragile-X syndrome, or childhood disintegrative disorder.

  • Prior DSM-5-TR diagnosis of intellectual disability (IQ < 70) for schizophrenia andbipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectualdisability (IQ < 25) for ASD participants.

  • Participant has a condition or is in a situation, which, in the investigator'sopinion, may put the participant at significant risk, may confound the studyresults, or may interfere significantly with the participant's participation in thestudy.

Study Design

Total Participants: 310
Treatment Group(s): 1
Primary Treatment: Cariprazine Flexible Dose
Phase: 3
Study Start date:
February 01, 2021
Estimated Completion Date:
October 06, 2025

Connect with a study center

  • Dr. Samuel Sanchez PSC /ID# 246047

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • Dr. Samuel Sanchez PSC /ID# 246047

    Caguas 4563008, 00727
    Puerto Rico

    Site Not Available

  • GCM Medical Group PSC /ID# 246048

    San Juan, 00917-3104
    Puerto Rico

    Site Not Available

  • GCM Medical Group PSC /ID# 246048

    San Juan 4568127, 00917-3104
    Puerto Rico

    Site Not Available

  • Harmonex Neuroscience Research /ID# 234938

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Harmonex Neuroscience Research /ID# 234938

    Dothan 4059102, Alabama 4829764 36303
    United States

    Site Not Available

  • Pillar Clinical Research /ID# 236434

    Bentonville, Arkansas 72712
    United States

    Site Not Available

  • Woodland International Research Group /ID# 236352

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Pillar Clinical Research /ID# 236434

    Bentonville 4101260, Arkansas 4099753 72712
    United States

    Site Not Available

  • Advanced Research Center /ID# 241903

    Anaheim, California 92805
    United States

    Site Not Available

  • Sun Valley Research Center /ID# 251054

    Imperial, California 92251-9401
    United States

    Site Not Available

  • Alliance for Research - Long Beach /ID# 236261

    Long Beach, California 90807
    United States

    Completed

  • Duplicate_Alliance for Research - Long Beach /ID# 236261

    Long Beach, California 90807
    United States

    Site Not Available

  • ATP Clinical Research- Orange /ID# 257095

    Orange, California 92868
    United States

    Site Not Available

  • CHOC Children's Hospital /ID# 251019

    Orange, California 92868-4203
    United States

    Site Not Available

  • Prospective Research Innovations Inc /ID# 236098

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • University of California, San Diego Department of Psychiatry /ID# 236466

    San Diego, California 92103-8229
    United States

    Site Not Available

  • Pacific Clinical Research Management Group /ID# 234377

    Upland, California 91786
    United States

    Site Not Available

  • Advanced Research Center /ID# 241903

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Duplicate_Alliance for Research - Long Beach /ID# 236261

    Long Beach 5367929, California 5332921 90807
    United States

    Site Not Available

  • ATP Clinical Research- Orange /ID# 257095

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • CHOC Children's Hospital /ID# 251019

    Orange 5379513, California 5332921 92868-4203
    United States

    Site Not Available

  • Prospective Research Innovations Inc /ID# 236098

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Site Not Available

  • University of California, San Diego Department of Psychiatry /ID# 236466

    San Diego 5391811, California 5332921 92103-8229
    United States

    Site Not Available

  • Pacific Clinical Research Management Group /ID# 234377

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • D&H Doral Research Center-Doral /ID# 255459

    Doral, Florida 33122
    United States

    Site Not Available

  • Sarkis Clinical Trials /ID# 236893

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Galiz Research - Palmetto Medical Plaza /ID# 236277

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Galiz Research- Palmetto Medical Plaza /ID# 236277

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Advanced Research Institute of Miami /ID# 242505

    Homestead, Florida 33030-4613
    United States

    Site Not Available

  • Sandhill Research LLC /ID# 251239

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Axcess Medical Research /ID# 251527

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • K2 Medical Research /ID# 257528

    Maitland, Florida 32751-5669
    United States

    Site Not Available

  • Columbus Clinical Services, Llc /Id# 234281

    Miami, Florida 33125
    United States

    Site Not Available

  • Florida Research Center, Inc. /ID# 236515

    Miami, Florida 33174
    United States

    Site Not Available

  • G+C Research Group, LLC /ID# 261398

    Miami, Florida 33126-2018
    United States

    Site Not Available

  • Links Clinical Trials /ID# 240975

    Miami, Florida 33176-3227
    United States

    Site Not Available

  • South Florida Research Ph I-IV /ID# 237453

    Miami Springs, Florida 33166-7225
    United States

    Site Not Available

  • APG Research, LLC /ID# 251153

    Orlando, Florida 32803
    United States

    Site Not Available

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528

    Orlando, Florida 32751
    United States

    Site Not Available

  • D&H Tamarac Research Center /ID# 250435

    Tamarac, Florida 33321-2979
    United States

    Site Not Available

  • D&H Doral Research Center-Doral /ID# 255459

    Doral 4153471, Florida 4155751 33122
    United States

    Site Not Available

  • Sarkis Clinical Trials /ID# 236893

    Gainesville 4156404, Florida 4155751 32607
    United States

    Site Not Available

  • Galiz Research- Palmetto Medical Plaza /ID# 236277

    Hialeah 4158476, Florida 4155751 33016
    United States

    Site Not Available

  • Advanced Research Institute of Miami /ID# 242505

    Homestead 4159050, Florida 4155751 33030-4613
    United States

    Site Not Available

  • Duplicate_Sandhill Research LLC /ID# 251239

    Lake Mary 4161373, Florida 4155751 32746
    United States

    Site Not Available

  • Columbus Clinical Services, Llc /Id# 234281

    Miami 4164138, Florida 4155751 33125
    United States

    Site Not Available

  • Florida Research Center, Inc. /ID# 236515

    Miami 4164138, Florida 4155751 33174
    United States

    Site Not Available

  • G+C Research Group, LLC /ID# 261398

    Miami 4164138, Florida 4155751 33126-2018
    United States

    Site Not Available

  • Links Clinical Trials /ID# 240975

    Miami 4164138, Florida 4155751 33176-3227
    United States

    Site Not Available

  • South Florida Research Ph I-IV /ID# 237453

    Miami Springs 4164223, Florida 4155751 33166-7225
    United States

    Site Not Available

  • APG Research, LLC /ID# 251153

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528

    Orlando 4167147, Florida 4155751 32751
    United States

    Site Not Available

  • D&H Tamarac Research Center /ID# 250435

    Tamarac 4174738, Florida 4155751 33321-2979
    United States

    Site Not Available

  • Atlanta Center for Medical Research /ID# 234698

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • CenExcel iResearch LLC /ID# 237391

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Atlanta Behavioral Research, LLC /ID# 236374

    Dunwoody, Georgia 30338
    United States

    Site Not Available

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 242611

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Atlanta Center for Medical Research /ID# 234698

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • CenExcel iResearch LLC /ID# 237391

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Atlanta Behavioral Research, LLC /ID# 236374

    Dunwoody 4192375, Georgia 4197000 30338
    United States

    Site Not Available

  • Ascension St. Elizabeth /ID# 235857

    Chicago, Illinois 60622
    United States

    Site Not Available

  • Ascension Illinois /ID# 235857

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Ascension Illinois /ID# 235857

    Hoffman Estates 4896075, Illinois 4896861 60169
    United States

    Site Not Available

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana 70629
    United States

    Site Not Available

  • The Kennedy Krieger Institute /ID# 236360

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Med Clinical Research Partners LLC /ID# 236071

    Irvington, New Jersey 07111
    United States

    Site Not Available

  • Med Clinical Research Partners LLC /ID# 236071

    Irvington 5099724, New Jersey 5101760 07111
    United States

    Site Not Available

  • Erie County Medical Center /ID# 237204

    Buffalo, New York 14215
    United States

    Site Not Available

  • Finger Lakes Clinical Research /ID# 236579

    Rochester, New York 14618-1609
    United States

    Site Not Available

  • Erie County Medical Center /ID# 237204

    Buffalo 5110629, New York 5128638 14215
    United States

    Site Not Available

  • New Dawn Psychiatric Services PLLC /ID# 236597

    Kinston, North Carolina 28501-1603
    United States

    Site Not Available

  • New Dawn Psychiatric Services PLLC /ID# 236597

    Kinston 4474436, North Carolina 4482348 28501-1603
    United States

    Site Not Available

  • Quest Therapeutics of Avon Lake /ID# 235956

    Avon Lake, Ohio 44012
    United States

    Site Not Available

  • Cincinnati Children's Hospital /ID# 251020

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Cincinnati /ID# 236913

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • CincyScience /ID# 236390

    West Chester, Ohio 45069
    United States

    Site Not Available

  • Quest Therapeutics of Avon Lake /ID# 235956

    Avon Lake 5146286, Ohio 5165418 44012
    United States

    Site Not Available

  • Cincinnati Children's Hospital /ID# 251020

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • University of Cincinnati /ID# 236913

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • CincyScience /ID# 236390

    West Chester 4520522, Ohio 5165418 45069
    United States

    Site Not Available

  • Cutting Edge Research Group /ID# 236664

    Oklahoma City, Oklahoma 73116-1423
    United States

    Site Not Available

  • Cutting Edge Research Group /ID# 236664

    Oklahoma City 4544349, Oklahoma 4544379 73116-1423
    United States

    Site Not Available

  • BioBehavioral Research of Austin /ID# 236479

    Austin, Texas 78759
    United States

    Site Not Available

  • Houston Clinical Trials /ID# 234444

    Bellaire, Texas 77401-2928
    United States

    Site Not Available

  • Cedar Health Research /ID# 259364

    Dallas, Texas 75251-2202
    United States

    Site Not Available

  • Relaro Medical Trials /ID# 241960

    Dallas, Texas 75243
    United States

    Site Not Available

  • McGovern Medical School /ID# 238506

    Houston, Texas 77054
    United States

    Site Not Available

  • Red Oak Psychiatry Associates /ID# 236602

    Houston, Texas 77090-2641
    United States

    Site Not Available

  • AIM Trials /ID# 236368

    Plano, Texas 75093
    United States

    Site Not Available

  • Family Psychiatry of The Woodlands /ID# 236426

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • BioBehavioral Research of Austin /ID# 236479

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Cedar Health Research /ID# 259364

    Dallas 4684888, Texas 4736286 75251-2202
    United States

    Site Not Available

  • Red Oak Psychiatry Associates /ID# 236602

    Houston 4699066, Texas 4736286 77090-2641
    United States

    Site Not Available

  • AIM Trials /ID# 236368

    Plano 4719457, Texas 4736286 75093
    United States

    Site Not Available

  • Family Psychiatry of The Woodlands /ID# 236426

    The Woodlands 4736476, Texas 4736286 77381
    United States

    Site Not Available

  • University of Virginia /ID# 236362

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Core Clinical Research /ID# 236409

    Everett, Washington 98201
    United States

    Site Not Available

  • Core Clinical Research /ID# 236409

    Everett 5793933, Washington 5815135 98201
    United States

    Site Not Available

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