Cariprazine for Pediatric Schizophrenia
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is Cariprazine safe for children with schizophrenia?
Cariprazine appears to be generally safe and well-tolerated in children and adolescents with schizophrenia, with most side effects being mild to moderate, such as sedation and tremor. No serious adverse events were reported in studies, and safety measures were similar to those observed in adults.12345
How is the drug Cariprazine unique for treating pediatric schizophrenia?
Cariprazine is unique because it is a third-generation antipsychotic that specifically targets dopamine D3 receptors, which may help with negative symptoms of schizophrenia that are often hard to treat. It also has a longer half-life, meaning it stays in the body longer, which can help reduce the frequency of relapses.12678
What data supports the effectiveness of the drug Cariprazine for pediatric schizophrenia?
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cariprazine for long-term safety and tolerability evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cariprazine
Cariprazine is already approved in United States for the following indications:
- Schizophrenia
- Acute manic or mixed episodes associated with bipolar I disorder
- Depressive episodes associated with bipolar I disorder (bipolar depression)
- Adjunctive treatment with an antidepressant therapy (ADT) for major depressive disorder (MDD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Allergan
Lead Sponsor
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
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