Cariprazine for Pediatric Schizophrenia

(3070 Ped OLE Trial)

No longer recruiting at 58 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety and benefits of cariprazine, an antipsychotic medication, for young people with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD). The study aims to evaluate the medication's effectiveness and safety over time. Suitable participants include those diagnosed with one of these conditions, experiencing symptoms that impact daily life, and having a caregiver to assist with study requirements. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment option.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cariprazine is generally safe and well-tolerated in young people. In a previous study with children and teens aged 10 to 17, cariprazine proved both safe and effective for treating psychiatric symptoms. Another study found that only 3% of patients experienced serious side effects, while 38% had side effects thought to be related to the treatment. The most common side effects occurred in more than 5% of cases, but specific details about these side effects were not provided. Overall, the evidence suggests that cariprazine is a promising option for treating schizophrenia in children, although more studies are needed to confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Cariprazine is unique because it works differently than many standard treatments for pediatric schizophrenia, such as risperidone or aripiprazole. Unlike these treatments, which primarily target dopamine D2 receptors, cariprazine also targets dopamine D3 receptors. This dual action may offer benefits in addressing both positive and negative symptoms of schizophrenia. Researchers are excited about cariprazine because its distinctive mechanism could lead to improved outcomes for young patients who have limited options.

What evidence suggests that cariprazine might be an effective treatment for pediatric schizophrenia, bipolar I disorder, or autism spectrum disorder?

Research shows that cariprazine effectively treats schizophrenia in children and teens. Studies have found it greatly improves symptoms in young people aged 13 to 17. In this trial, participants with schizophrenia will receive cariprazine. Cariprazine is also safe and easy to tolerate, making it a promising choice for young people with schizophrenia. For those with bipolar I disorder, cariprazine has proven both effective and easy to tolerate, and participants with bipolar I disorder in this trial will also receive cariprazine. While more information is needed for autism spectrum disorder, the treatment's success in similar conditions offers hope, and participants with autism spectrum disorder will receive cariprazine in this trial as well. ^{5 6 7 8 9}

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

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]

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]

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31825249/

Cariprazine in Youth with Bipolar and Psychotic Disorders Conclusions: Cariprazine may be well tolerated and effective for pediatric bipolar and psychotic disorders; however, compared with higher doses, total daily ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11421304/

Cariprazine in Psychiatry: A Comprehensive Review of ... The study conducted by Riccobene et al showed the effectiveness of cariprazine in pediatric patients with schizophrenia (13–17 years old) or ...

3. vraylarhcp.com vraylarhcp.com/efficacy/schizophrenia-efficacy

VRAYLAR® (cariprazine) Efficacy for Schizophrenia VRAYLAR significantly improved overall schizophrenia symptoms1-4* ; Study 1 · Line graph showing PANSS total score in schizophrenia study 1. · 97.3. Placebo (n=148).

4. psychopharmacologyinstitute.com psychopharmacologyinstitute.com/section/safety-and-tolerability-of-cariprazine-in-pediatric-patients-2750-5474/

03. Safety and Tolerability of Cariprazine in Pediatric Patients Cariprazine was safe and well-tolerated in pediatric patients with schizophrenia and bipolar I disorder and may be associated with favorable ...

5. liebertpub.com liebertpub.com/doi/10.1089/cap.2021.0139

Pharmacokinetics, Safety, and Tolerability of Cariprazine in ... Cariprazine appeared to be safe and well-tolerated in a pediatric population aged 10–17 years. The psychiatric symptom improvement provides support for future ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10292137/

Cariprazine for Treating Schizophrenia, Mania, Bipolar ... Overall, the available evidence suggests that cariprazine is a safe and effective treatment option for schizophrenia, but further research is ...

7. jaacap.org jaacap.org/article/S0890-8567(25)01522-9/fulltext

1.40 Long-Term Safety of Cariprazine in Pediatric Patients ... Serious AEs were reported by 3% of patients overall, and 38% experienced AEs considered treatment-related by the investigator. Common AEs (≥5% in any indication) ...

8. vraylarhcp.com vraylarhcp.com/safety

VRAYLAR® (cariprazine) Tolerability and Safety Safety and effectiveness of VRAYLAR have not been established in pediatric patients. Contraindication: VRAYLAR is contraindicated in patients with known ...

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00061/full

Cariprazine Safety in Adolescents and the Elderly Cariprazine in the approved adult dose-range of 1.5–6 mg might be a safe treatment option also in adolescent and elderly patients with schizophrenia.