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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Bipolar I Disorder; Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Drug: Cariprazine Flexible Dose

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Recruiting
    • Dr. Samuel Sanchez PSC /ID# 246047
  • San Juan, Puerto Rico, 00917-3104
    • Recruiting
    • GCM Medical Group PSC /ID# 246048
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Recruiting
      • Harmonex Neuroscience Research /ID# 234938
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Completed
      • Pillar Clinical Research /ID# 236434
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Advanced Research Center /ID# 241903
    • Long Beach, California, United States, 90807
      • Completed
      • Alliance for Research - Long Beach /ID# 236261
    • Orange, California, United States, 92868-4203
      • Recruiting
      • CHOC Children's Hospital /ID# 251019
    • Orange, California, United States, 92868
      • Recruiting
      • ATP Clinical Research- Orange /ID# 257095
    • Rancho Cucamonga, California, United States, 91730
      • Recruiting
      • Prospective Research Innovations Inc /ID# 236098
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • San Diego, California, United States, 92103-8229
      • Completed
      • University of California, San Diego Department of Psychiatry /ID# 236466
    • Upland, California, United States, 91786-3676
      • Recruiting
      • Pacific Clinical Research Management Group /ID# 234377
  • Florida
    • Doral, Florida, United States, 33122
      • Recruiting
      • D&H Doral Research Center-Doral /ID# 255459
    • Gainesville, Florida, United States, 32607
      • Recruiting
      • Sarkis Clinical Trials /ID# 236893
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Hialeah, Florida, United States, 33016
      • Completed
      • Galiz Research- Palmetto Medical Plaza /ID# 236277
    • Homestead, Florida, United States, 33030-4613
      • Recruiting
      • Advanced Research Institute of Miami /ID# 242505
    • Lake Mary, Florida, United States, 32746
      • Recruiting
      • Sandhill Research LLC /ID# 251239
    • Maitland, Florida, United States, 32751-5669
      • Recruiting
      • K2 Medical Research /ID# 257528
    • Miami, Florida, United States, 33125-5114
      • Recruiting
      • Columbus Clinical Services, Llc /Id# 234281
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Miami, Florida, United States, 33174
      • Recruiting
      • Florida Research Center, Inc. /ID# 236515
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Miami, Florida, United States, 33176-3227
      • Recruiting
      • Links Clinical Trials /ID# 240975
    • Miami, Florida, United States, 33126-2018
      • Recruiting
      • G+C Research Group, LLC /ID# 261398
    • Miami Springs, Florida, United States, 33166-7225
      • Recruiting
      • South Florida Research Ph I-IV /ID# 237453
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • Orlando, Florida, United States, 32803
      • Recruiting
      • APG Research, LLC /ID# 251153
    • Tamarac, Florida, United States, 33321-2979
      • Recruiting
      • D&H Tamarac Research Center /ID# 250435
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Recruiting
      • Atlanta Center for Medical Research /ID# 234698
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExcel iResearch LLC /ID# 237391
    • Dunwoody, Georgia, United States, 30338
      • Recruiting
      • Atlanta Behavioral Research, LLC /ID# 236374
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Illinois
    • Chicago, Illinois, United States, 60622
      • Recruiting
      • Ascension St. Elizabeth /ID# 235857
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • New Jersey
    • Irvington, New Jersey, United States, 07111
      • Recruiting
      • Med Clinical Research Partners LLC /ID# 236071
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • New York
    • Buffalo, New York, United States, 14215
      • Completed
      • Erie County Medical Center /ID# 237204
  • North Carolina
    • Kinston, North Carolina, United States, 28501-1603
      • Recruiting
      • New Dawn Psychiatric Services PLLC /ID# 236597
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Recruiting
      • Quest Therapeutics of Avon Lake /ID# 235956
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati /ID# 236913
      • Contact: Site Coordinator; Phone Number: 844-663-3742
    • West Chester, Ohio, United States, 45069
      • Recruiting
      • CincyScience /ID# 236390
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116-1423
      • Recruiting
      • Cutting Edge Research Group /ID# 236664
      • Contact: Site Coordinator; Phone Number: 844-663-3742
  • Texas
    • Austin, Texas, United States, 78759-5290
      • Recruiting
      • BioBehavioral Research of Austin /ID# 236479
      • Contact: Site Coordinator; Phone Number: (512) 382-6661
    • Houston, Texas, United States, 77090-2641
      • Recruiting
      • Red Oak Psychiatry Associates /ID# 236602
    • Plano, Texas, United States, 75093
      • Recruiting
      • AIM Trials /ID# 236368
    • The Woodlands, Texas, United States, 77381
      • Recruiting
      • Family Psychiatry of The Woodlands /ID# 236426
  • Washington
    • Everett, Washington, United States, 98201
      • Recruiting
      • Core Clinical Research /ID# 236409
      • Contact: Site Coordinator; Phone Number: 425-443-9551

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cariprazine Dose 1; Participants with Schizophrenia (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 2; Participants with Schizophrenia (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 3; Participants with Bipolar I Disorder (age 10 to 12 years and <40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 4; Participants with Bipolar I Disorder (age 10 to 12 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 5; Participants with Bipolar I Disorder (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 6; Participants with Bipolar I Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 7; Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 8; Participants with Autism Spectrum Disorder (age 10 to 12 years and <40 kg weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 9; Participants with Autism Spectrum Disorder (age 10 to 12 years and >=40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 10; Participants with Autism Spectrum Disorder (age 13 to 17 years and <40 kg weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)
Experimental: Cariprazine Dose 11; Participants with Autism Spectrum Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.	Drug: Cariprazine Flexible Dose; 1 capsule to be taken orally at approximately the same time of day (morning or evening)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): June 24, 2025
• Study Completion (Estimated): June 24, 2025

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Bipolar I Disorder; Cariprazine; Autism Spectrum Disorder (ASD)
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurodevelopmental Disorders; Schizophrenia; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Cariprazine
• Other Study ID Numbers: 3070-301-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No