Cariprazine for Pediatric Schizophrenia
Recruiting at56 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Allergan
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial is testing the safety and effectiveness of cariprazine in children and teens with schizophrenia, bipolar I disorder, or autism. The goal is to see if the medication is safe and beneficial for use in these young patients.
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for children and teens with schizophrenia, bipolar I disorder, or autism spectrum disorder. They must be able to swallow pills, have normal health check results or non-serious irregularities, and if sexually active, agree to use birth control. A caregiver must oversee their treatment and give informed consent.Inclusion Criteria
I have been diagnosed with schizophrenia, bipolar I, or autism.
A negative serum β-hCG pregnancy test in women aged 18 years or older.
I am willing to take daily medication and undergo required tests for the study.
See 7 more
Exclusion Criteria
Is the patient currently diagnosed with major depressive disorder, schizoaffective disorder, or a substance use disorder?
Has the patient been hospitalized for a psychiatric reason within the past 6 months?
Treatment Details
Interventions
- Cariprazine (Atypical Antipsychotic)
Trial OverviewThe study tests the long-term safety of Cariprazine in young patients with certain mental health conditions. It aims to understand the risks and benefits of extended use by observing participants over time as they take varying doses of this medication.
Participant Groups
11Treatment groups
Experimental Treatment
Group I: Cariprazine Dose 9Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 10 to 12 years and \>=40 kg body weight) will receive cariprazine.
Group II: Cariprazine Dose 8Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 10 to 12 years and \<40 kg weight) will receive cariprazine.
Group III: Cariprazine Dose 7Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.
Group IV: Cariprazine Dose 6Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Group V: Cariprazine Dose 5Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.
Group VI: Cariprazine Dose 4Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 10 to 12 years and \>= 40 kg body weight) will receive cariprazine.
Group VII: Cariprazine Dose 3Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 10 to 12 years and \<40 kg body weight) will receive cariprazine.
Group VIII: Cariprazine Dose 2Experimental Treatment1 Intervention
Participants with Schizophrenia (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Group IX: Cariprazine Dose 11Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.
Group X: Cariprazine Dose 10Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 13 to 17 years and \<40 kg weight) will receive cariprazine.
Group XI: Cariprazine Dose 1Experimental Treatment1 Intervention
Participants with Schizophrenia (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Allergan
Lead Sponsor
Trials
782
Recruited
277,000+
Brent Saunders
Allergan
Chief Executive Officer since 2015
JD and MBA from Temple University
Dr. David Nicholson
Allergan
Chief Medical Officer since 2015
MD from Harvard Medical School
AbbVie
Lead Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois