Cariprazine for Pediatric Schizophrenia

Recruiting at 56 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Disqualifiers: Major depressive, Schizoaffective, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

310 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

What data supports the effectiveness of the drug Cariprazine for pediatric schizophrenia?

Cariprazine has been shown to be effective in treating schizophrenia in adults, improving symptoms significantly more than a placebo. In studies with young people, it has been used for bipolar and psychotic disorders, showing potential effectiveness and being generally well tolerated. ^{1 2 3 5 8}

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

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.

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?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cariprazine for long-term safety and tolerability evaluation

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cariprazine

Trial Overview 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.

How Is the Trial Designed?

Group I: Cariprazine Dose 9 Experimental Treatment 1 Intervention

Participants with Autism Spectrum Disorder (age 10 to 12 years and \>=40 kg body weight) will receive cariprazine.

Group II: Cariprazine Dose 8 Experimental Treatment 1 Intervention

Participants with Autism Spectrum Disorder (age 10 to 12 years and \<40 kg weight) will receive cariprazine.

Group III: Cariprazine Dose 7 Experimental Treatment 1 Intervention

Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.

Group IV: Cariprazine Dose 6 Experimental Treatment 1 Intervention

Participants with Bipolar I Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.

Group V: Cariprazine Dose 5 Experimental Treatment 1 Intervention

Participants with Bipolar I Disorder (age 13 to 17 years and \< 40 kg body weight) will receive cariprazine.

Group VI: Cariprazine Dose 4 Experimental Treatment 1 Intervention

Participants with Bipolar I Disorder (age 10 to 12 years and \>= 40 kg body weight) will receive cariprazine.

Group VII: Cariprazine Dose 3 Experimental Treatment 1 Intervention

Participants with Bipolar I Disorder (age 10 to 12 years and \<40 kg body weight) will receive cariprazine.

Group VIII: Cariprazine Dose 2 Experimental Treatment 1 Intervention

Participants with Schizophrenia (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.

Group IX: Cariprazine Dose 11 Experimental Treatment 1 Intervention

Participants with Autism Spectrum Disorder (age 13 to 17 years and \>= 40 kg body weight) will receive cariprazine.

Group X: Cariprazine Dose 10 Experimental Treatment 1 Intervention

Participants with Autism Spectrum Disorder (age 13 to 17 years and \<40 kg weight) will receive cariprazine.

Group XI: Cariprazine Dose 1 Experimental Treatment 1 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)

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

Published Research Related to This Trial

In clinical trials, cariprazine significantly improved schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS), and showed a longer time to relapse in a long-term study.

Cariprazine was more effective than risperidone in treating negative symptoms of schizophrenia, which are often challenging to address, and it was generally well tolerated with mostly mild to moderate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine: A Review in Schizophrenia. Garnock-Jones, KP.[2018]

In a review of 16 patients aged 6-20 treated with cariprazine for bipolar and psychotic disorders, the medication showed a 44% response rate, indicating potential effectiveness in this age group.

While no serious adverse events were reported, weight gain was a common side effect, particularly at doses higher than 3 mg/day, suggesting that lower doses may be more tolerable for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine in Youth with Bipolar and Psychotic Disorders: A Retrospective Chart Review. Poweleit, EA., Colestock, M., Kantemneni, EC., et al.[2021]

Cariprazine is effective for treating schizophrenia and bipolar I disorder, showing a favorable side effect profile due to its selective affinity for D3 receptors, which helps address a range of symptoms including negative and cognitive symptoms.

It has a longer half-life and a delayed relapse time compared to other second-generation antipsychotics, making it a potentially better option for patients with high rates of non-adherence and frequent relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Symptom Clusters in Schizophrenia, Bipolar Disorder and Major Depressive Disorder With the Dopamine D3/D2 Preferring Partial Agonist Cariprazine. Batinic, B., Ristic, I., Zugic, M., et al.[2021]

Cariprazine (Vraylar) is an atypical antipsychotic that acts as a partial agonist at dopamine D3 and D2 receptors, with a preference for D3, and also affects serotonin 5-HT1A receptors, which contributes to its therapeutic effects.

Approved in the USA in September 2015, cariprazine is used to treat schizophrenia and acute manic or mixed episodes in bipolar I disorder, and is being explored for additional uses in treating negative symptoms of schizophrenia and bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine: First Global Approval. McCormack, PL.[2018]

Cariprazine was found to be generally safe and well tolerated in both adolescent (49 patients) and elderly (17 patients) populations with schizophrenia, with adverse events similar to those seen in adults, except for less insomnia in adolescents and no akathisia in the elderly.

The study suggests that the approved adult dosage of cariprazine (1.5-6 mg) may also be appropriate for treating schizophrenia in younger and older patients, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data. Szatmári, B., Barabássy, Á., Harsányi, J., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Cariprazine: A Review in Schizophrenia. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Cariprazine in Youth with Bipolar and Psychotic Disorders: A Retrospective Chart Review. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Symptom Clusters in Schizophrenia, Bipolar Disorder and Major Depressive Disorder With the Dopamine D3/D2 Preferring Partial Agonist Cariprazine. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cariprazine: First Global Approval. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Cariprazine: chemistry, pharmacodynamics, pharmacokinetics, and metabolism, clinical efficacy, safety, and tolerability. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Long-Acting Oral Cariprazine. [2023]