Phase
Condition
Tourette's Syndrome
Asperger's Disorder
Autism
Treatment
Cariprazine Flexible Dose
Clinical Study ID
Ages 5-17 All Genders
Study Summary
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
Connect with a study center
Dr. Samuel Sanchez PSC /ID# 246047
Caguas, 00727
Puerto RicoSite Not Available
GCM Medical Group PSC /ID# 246048
San Juan, 00917-3104
Puerto RicoSite Not Available
Harmonex Neuroscience Research /ID# 234938
Dothan, Alabama 36303
United StatesSite Not Available
Pillar Clinical Research /ID# 236434
Bentonville, Arkansas 72712
United StatesSite Not Available
Woodland International Research Group /ID# 236352
Little Rock, Arkansas 72211
United StatesSite Not Available
Advanced Research Center /ID# 241903
Anaheim, California 92805
United StatesSite Not Available
Sun Valley Research Center /ID# 251054
Imperial, California 92251-9401
United StatesSite Not Available
Alliance for Research - Long Beach /ID# 236261
Long Beach, California 90807
United StatesCompleted
Duplicate_Alliance for Research - Long Beach /ID# 236261
Long Beach, California 90807
United StatesSite Not Available
ATP Clinical Research- Orange /ID# 257095
Orange, California 92868
United StatesSite Not Available
CHOC Children's Hospital /ID# 251019
Orange, California 92868-4203
United StatesSite Not Available
Prospective Research Innovations Inc /ID# 236098
Rancho Cucamonga, California 91730
United StatesSite Not Available
University of California, San Diego Department of Psychiatry /ID# 236466
San Diego, California 92103-8229
United StatesSite Not Available
Pacific Clinical Research Management Group /ID# 234377
Upland, California 91786
United StatesSite Not Available
D&H Doral Research Center-Doral /ID# 255459
Doral, Florida 33122
United StatesSite Not Available
Sarkis Clinical Trials /ID# 236893
Gainesville, Florida 32607
United StatesSite Not Available
Galiz Research - Palmetto Medical Plaza /ID# 236277
Hialeah, Florida 33016
United StatesActive - Recruiting
Galiz Research- Palmetto Medical Plaza /ID# 236277
Hialeah, Florida 33016
United StatesSite Not Available
Advanced Research Institute of Miami /ID# 242505
Homestead, Florida 33030-4613
United StatesSite Not Available
Sandhill Research LLC /ID# 251239
Lake Mary, Florida 32746
United StatesSite Not Available
Axcess Medical Research /ID# 251527
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
K2 Medical Research /ID# 257528
Maitland, Florida 32751-5669
United StatesSite Not Available
Columbus Clinical Services, Llc /Id# 234281
Miami, Florida 33125-5114
United StatesSite Not Available
Florida Research Center, Inc. /ID# 236515
Miami, Florida 33174
United StatesSite Not Available
G+C Research Group, LLC /ID# 261398
Miami, Florida 33126-2018
United StatesSite Not Available
Links Clinical Trials /ID# 240975
Miami, Florida 33176-3227
United StatesSite Not Available
South Florida Research Ph I-IV /ID# 237453
Miami Springs, Florida 33166-7225
United StatesSite Not Available
APG Research, LLC /ID# 251153
Orlando, Florida 32803
United StatesSite Not Available
K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528
Orlando, Florida 32751
United StatesSite Not Available
D&H Tamarac Research Center /ID# 250435
Tamarac, Florida 33321-2979
United StatesSite Not Available
Atlanta Center for Medical Research /ID# 234698
Atlanta, Georgia 30331
United StatesSite Not Available
CenExcel iResearch LLC /ID# 237391
Decatur, Georgia 30030
United StatesSite Not Available
Atlanta Behavioral Research, LLC /ID# 236374
Dunwoody, Georgia 30338
United StatesSite Not Available
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 242611
Stockbridge, Georgia 30281
United StatesSite Not Available
Ascension St. Elizabeth /ID# 235857
Chicago, Illinois 60622
United StatesSite Not Available
Lake Charles Clinical Trials
Lake Charles, Louisiana 70629
United StatesSite Not Available
The Kennedy Krieger Institute /ID# 236360
Baltimore, Maryland 21205
United StatesSite Not Available
Med Clinical Research Partners LLC /ID# 236071
Irvington, New Jersey 07111
United StatesSite Not Available
Erie County Medical Center /ID# 237204
Buffalo, New York 14215
United StatesSite Not Available
Finger Lakes Clinical Research /ID# 236579
Rochester, New York 14618-1609
United StatesSite Not Available
New Dawn Psychiatric Services PLLC /ID# 236597
Kinston, North Carolina 28501-1603
United StatesSite Not Available
Quest Therapeutics of Avon Lake /ID# 235956
Avon Lake, Ohio 44012
United StatesSite Not Available
Cincinnati Children's Hospital /ID# 251020
Cincinnati, Ohio 45229
United StatesSite Not Available
University of Cincinnati /ID# 236913
Cincinnati, Ohio 45219
United StatesSite Not Available
CincyScience /ID# 236390
West Chester, Ohio 45069
United StatesSite Not Available
Cutting Edge Research Group /ID# 236664
Oklahoma City, Oklahoma 73116-1423
United StatesSite Not Available
BioBehavioral Research of Austin /ID# 236479
Austin, Texas 78759
United StatesSite Not Available
Houston Clinical Trials /ID# 234444
Bellaire, Texas 77401-2928
United StatesSite Not Available
Cedar Health Research /ID# 259364
Dallas, Texas 75251-2202
United StatesSite Not Available
Relaro Medical Trials /ID# 241960
Dallas, Texas 75243
United StatesSite Not Available
McGovern Medical School /ID# 238506
Houston, Texas 77054
United StatesSite Not Available
Red Oak Psychiatry Associates /ID# 236602
Houston, Texas 77090-2641
United StatesSite Not Available
AIM Trials /ID# 236368
Plano, Texas 75093
United StatesSite Not Available
Family Psychiatry of The Woodlands /ID# 236426
The Woodlands, Texas 77381
United StatesSite Not Available
University of Virginia /ID# 236362
Charlottesville, Virginia 22903
United StatesSite Not Available
Core Clinical Research /ID# 236409
Everett, Washington 98201
United StatesSite Not Available
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