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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578756
• Other study ID #: 3070-301-001
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: June 24, 2025

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 24, 2025
• Est. primary completion date: June 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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, ocular assessments, and ECGs, of which the results enabled ongoing trial participation. As such, eligibility for participants enrolling from these parent studies need not be contingent on results of these tests but participants must be withdrawn if results of these tests meet withdrawal criteria.
• 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.
• The 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Bipolar I Disorder
• Child Development Disorders, Pervasive
• Schizophrenia

Intervention

Drug:
• Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)

Locations

Country	Name	City	State
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 246047	Caguas
Puerto Rico	GCM Medical Group PSC /ID# 246048	San Juan
United States	Advanced Research Center /ID# 241903	Anaheim	California
United States	Atlanta Center for Medical Research /ID# 234698	Atlanta	Georgia
United States	BioBehavioral Research of Austin /ID# 236479	Austin	Texas
United States	Quest Therapeutics of Avon Lake /ID# 235956	Avon Lake	Ohio
United States	Pillar Clinical Research /ID# 236434	Bentonville	Arkansas
United States	Erie County Medical Center /ID# 237204	Buffalo	New York
United States	Ascension St. Elizabeth /ID# 235857	Chicago	Illinois
United States	University of Cincinnati /ID# 236913	Cincinnati	Ohio
United States	CenExcel iResearch LLC /ID# 237391	Decatur	Georgia
United States	D&H Doral Research Center-Doral /ID# 255459	Doral	Florida
United States	Harmonex Neuroscience Research /ID# 234938	Dothan	Alabama
United States	Atlanta Behavioral Research, LLC /ID# 236374	Dunwoody	Georgia
United States	Core Clinical Research /ID# 236409	Everett	Washington
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	Red Oak Psychiatry Associates /ID# 236602	Houston	Texas
United States	Med Clinical Research Partners LLC /ID# 236071	Irvington	New Jersey
United States	New Dawn Psychiatric Services PLLC /ID# 236597	Kinston	North Carolina
United States	Sandhill Research LLC /ID# 251239	Lake Mary	Florida
United States	Alliance for Research - Long Beach /ID# 236261	Long Beach	California
United States	K2 Medical Research /ID# 257528	Maitland	Florida
United States	Columbus Clinical Services, Llc /Id# 234281	Miami	Florida
United States	Florida Research Center, Inc. /ID# 236515	Miami	Florida
United States	G+C Research Group, LLC /ID# 261398	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	Cutting Edge Research Group /ID# 236664	Oklahoma City	Oklahoma
United States	ATP Clinical Research- Orange /ID# 257095	Orange	California
United States	CHOC Children's Hospital /ID# 251019	Orange	California
United States	APG Research, LLC /ID# 251153	Orlando	Florida
United States	AIM Trials /ID# 236368	Plano	Texas
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	D&H Tamarac Research Center /ID# 250435	Tamarac	Florida
United States	Family Psychiatry of The Woodlands /ID# 236426	The Woodlands	Texas
United States	Pacific Clinical Research Management Group /ID# 234377	Upland	California
United States	CincyScience /ID# 236390	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.	Baseline Day 1 to Week 82
Primary	Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters	Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.	Baseline Day 1 to Week 52
Primary	Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters	Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.	Baseline Day 1 to Week 82
Primary	Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)	A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.	Baseline Day 1 to Week 52
Primary	Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale	C-SSRS is a clinician-rated scale that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 "wish to be dead," and 5 "active suicidal ideation with specific plan and intent". Suicidal behavior is classified on a 5-item scale: 0 "no suicidal behavior, and 4 "actual attempt".	Baseline Day 1 to Week 52
Primary	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.	Baseline Day 1 to Week 52
Primary	Change From Baseline in Barnes Akathisia Rating Scale (BARS)	BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).	Baseline Day 1 to Week 52
Primary	Change From Baseline in Simpson-Angus Scale (SAS)	SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.	Baseline Day 1 to Week 52
Primary	Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters	Ocular examination parameters included Intraocular pressure (IOP) measurement, Best-corrected visual acuity (BCVA), color fundus photography, color vision testing using Hardy Rand and Rittler (HRR) plates, and assessment of Optical coherence tomography (OCT) and cataracts. The investigator assessed the results for clinical significance.	Baseline Day 1 to Week 52
Primary	Number of Participants With Menstrual Onset Shift (Female Participants Only)	Female participants who have entered menarche will be asked for the date of the first day of their most recent menstrual period.	Baseline Day 1 to Week 52
Primary	Incidence of Participants Shifting in Tanner Staging	Tanner staging is a scale for assessing physical development in children, adolescents, and adults. The scale defines physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair.	Baseline Day 1 to Week 52

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