Cariprazine for Pediatric Schizophrenia

Recruiting in Palo Alto (17 mi)

+56 other 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.

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 am between 5 and 17 years old.

I am willing to take daily medication and undergo required tests for the study.

Exclusion Criteria

Has the patient been hospitalized for a psychiatric reason within the past 6 months?

Is the patient currently diagnosed with major depressive disorder, schizoaffective disorder, or a substance use disorder?

Participant Groups

The 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.

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.

Cariprazine is already approved in United States for the following indications:

🇺🇸 Approved in United States as Vraylar for:

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)