What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics like Cariprazine, often have side effects including metabolic syndrome (weight gain, diabetes, dyslipidemia), sedation, and cardiovascular issues. Cariprazine specifically may cause akathisia, insomnia, and gastrointestinal disturbances. Other similar medications, such as aripiprazole and quetiapine, share these side effects but may vary in their intensity and occurrence.

What prior FDA approvals exist?

Several second-generation antipsychotics have been approved by the FDA for the treatment of schizophrenia, including drugs with mechanisms similar to Cariprazine. Aripiprazole, like Cariprazine, is a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors. Other notable approvals include Risperidone, which primarily acts as a dopamine D2 and serotonin 5-HT2A receptor antagonist, and Quetiapine, which has a similar receptor profile but with additional effects on histamine and adrenergic receptors. These medications are used to manage symptoms of schizophrenia by modulating neurotransmitter activity in the brain.

What other types of research exist?

Promising novel alternatives to Cariprazine for schizophrenia treatment in 2024 include Brexpiprazole and Lumateperone. Brexpiprazole is a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, and an antagonist at serotonin 5-HT2A receptors, similar to Cariprazine. Lumateperone offers a novel mechanism by acting as a serotonin 5-HT2A receptor antagonist, dopamine D2 receptor presynaptic partial agonist and postsynaptic antagonist, and serotonin reuptake inhibitor, providing a multifaceted approach to treatment.

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Atypical Antipsychotic

Cariprazine for Pediatric Schizophrenia

Q: What is the mechanism of action of this treatment?

Second-generation antipsychotics, such as Cariprazine, work primarily by modulating dopamine and serotonin receptors. Cariprazine acts as a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, while also antagonizing serotonin 5-HT2A receptors. This dual action helps balance dopamine levels, which can reduce both positive symptoms (like hallucinations and delusions) and negative symptoms (such as social withdrawal and apathy) of schizophrenia. By targeting these specific receptors, these medications can offer effective symptom control with a potentially lower risk of side effects like extrapyramidal symptoms, which are more common with first-generation antipsychotics. This is particularly important for improving the overall quality of life and treatment adherence in schizophrenia patients.

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is the patient between the ages of 5 - 17 years old?

Is the patient willing to take the study medication daily and undergo study procedures such as EKGs, blood draws, physical, and eye exam?

Must not have

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?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline day 1 to week 59

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, common side effects for antipsychotic drugs like Cariprazine may include drowsiness, restlessness, weight gain, dry mouth, blurred vision and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 17 years old.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline day 1 to week 59

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline day 1 to week 59

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1 to week 59 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

Change From Baseline in Barnes Akathisia Rating Scale (BARS)

Change From Baseline in Simpson-Angus Scale (SAS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Second-generation antipsychotics, such as Cariprazine, work primarily by modulating dopamine and serotonin receptors. Cariprazine acts as a partial agonist at dopamine D2 and D3 receptors and serotonin 5-HT1A receptors, while also antagonizing serotonin 5-HT2A receptors. This dual action helps balance dopamine levels, which can reduce both positive symptoms (like hallucinations and delusions) and negative symptoms (such as social withdrawal and apathy) of schizophrenia. By targeting these specific receptors, these medications can offer effective symptom control with a potentially lower risk of side effects like extrapyramidal symptoms, which are more common with first-generation antipsychotics. This is particularly important for improving the overall quality of life and treatment adherence in schizophrenia patients.