Clinical trial NCT04578756: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Bipolar I Disorder
Autism Spectrum Disorder (ASD)
Keywords: Schizophrenia
Bipolar I Disorder
Cariprazine
Autism Spectrum Disorder (ASD)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 310
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
timeFrame: Baseline Day 1 to Week 59
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
timeFrame: Baseline Day 1 to Week 52
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
timeFrame: Baseline Day 1 to Week 59
measure: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
timeFrame: Baseline Day 1 to Week 52
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale
timeFrame: Baseline Day 1 to Week 52
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline Day 1 to Week 52
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS)
timeFrame: Baseline Day 1 to Week 52
measure: Change From Baseline in Simpson-Angus Scale (SAS)
timeFrame: Baseline Day 1 to Week 52
measure: Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters
timeFrame: Baseline Day 1 to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research /ID# 234938
state: Alabama
city: Bentonville
country: United States
facility: Pillar Clinical Research /ID# 236434
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 241903
state: California
city: Long Beach
country: United States
facility: Duplicate_Alliance for Research - Long Beach /ID# 236261
state: California
city: Orange
country: United States
facility: CHOC Children's Hospital /ID# 251019
state: California
city: Orange
country: United States
facility: ATP Clinical Research- Orange /ID# 257095
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc /ID# 236098
state: California
city: San Diego
country: United States
facility: University of California, San Diego Department of Psychiatry /ID# 236466
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group /ID# 234377
state: California
city: Doral
country: United States
facility: D&H Doral Research Center-Doral /ID# 255459
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials /ID# 236893
state: Florida
city: Hialeah
country: United States
facility: Galiz Research- Palmetto Medical Plaza /ID# 236277
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami /ID# 242505
state: Florida
city: Lake Mary
country: United States
facility: Sandhill Research LLC /ID# 251239
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Ph I-IV /ID# 237453
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, Llc /Id# 234281
state: Florida
city: Miami
country: United States
facility: G+C Research Group, LLC /ID# 261398
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc. /ID# 236515
state: Florida
city: Miami
country: United States
facility: Links Clinical Trials /ID# 240975
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC /ID# 251153
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center /ID# 250435
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research /ID# 234698
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch LLC /ID# 237391
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Behavioral Research, LLC /ID# 236374
state: Georgia
city: Chicago
country: United States
facility: Ascension St. Elizabeth /ID# 235857
state: Illinois
city: Irvington
country: United States
facility: Med Clinical Research Partners LLC /ID# 236071
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center /ID# 237204
state: New York
city: Kinston
country: United States
facility: New Dawn Psychiatric Services PLLC /ID# 236597
state: North Carolina
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 235956
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 236913
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital /ID# 251020
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 236390
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group /ID# 236664
state: Oklahoma
city: Austin
country: United States
facility: BioBehavioral Research of Austin /ID# 236479
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research /ID# 259364
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates /ID# 236602
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 236368
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 236426
state: Texas
city: Everett
country: United States
facility: Core Clinical Research /ID# 236409
state: Washington
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 246047
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 246048
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: