What side effects are associated with this type of intervention?

Atypical antipsychotics, such as Cariprazine, used to treat irritability and aggression in Autism Spectrum Disorder (ASD), commonly cause side effects including weight gain, metabolic changes (e.g., increased blood sugar and cholesterol), sedation, and extrapyramidal symptoms (e.g., tremors). There is also a risk of cardiovascular issues and endocrine disturbances, necessitating careful monitoring, particularly in children and adolescents.

What prior FDA approvals exist?

The FDA has approved two atypical antipsychotics for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. Both drugs modulate dopamine and serotonin receptors, similar to Cariprazine, and have shown efficacy in reducing symptoms such as aggression, self-injury, and severe tantrums in children and adolescents with ASD. These medications are part of a broader treatment plan that often includes behavioral interventions and other supportive therapies.

What other types of research exist?

Promising novel alternatives to Cariprazine for treating Autism Spectrum Disorder in 2024 include Aripiprazole and Risperidone, which are atypical antipsychotics known to modulate dopamine and serotonin receptors. Additionally, emerging treatments such as Brexpiprazole and Lurasidone are being studied for their potential benefits in managing ASD symptoms.

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Atypical Antipsychotic

Cariprazine for Autism Spectrum Disorder

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment 8 weeks

Follow Up 12 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug called cariprazine to see if it can help reduce irritability in children and teenagers with autism. The study involves taking the drug daily for a period of time and includes regular check-ups to monitor safety and effectiveness. The goal is to find out if cariprazine can improve behavior in young people with autism. Cariprazine has shown potential in alleviating core behavioral deficits and hyperactivity in animal models of autism spectrum disorder.

Who is the study for?

This trial is for children aged 5-17 with Autism Spectrum Disorder (ASD) who show significant irritability. They must have specific scores on clinical assessments that measure severity of irritability and confirm an ASD diagnosis. Participants will be randomly assigned to receive either the drug Cariprazine or a placebo.

What is being tested?

The study tests Cariprazine's safety and effectiveness in reducing irritability due to ASD compared to a placebo, over an 8-week treatment period followed by a 12-week safety follow-up. This double-blind trial means neither participants nor doctors know who receives the actual drug or placebo.

What are the potential side effects?

Potential side effects may include changes in mood or behavior, gastrointestinal issues, sleep disturbances, and other reactions typical of psychiatric medications. Specific side effects related to Cariprazine will be monitored throughout the study.

Timeline

Screening ~ 3 weeks2 visits

Treatment ~ 8 weeks8 visits

Follow Up ~ 12 weeks2 visits

Screening ~ 3 weeks

Treatment ~ 8 weeks

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, 8 weeks for treatment, and 12 weeks 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 Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score

Secondary study objectives

Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score

Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score

Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668

17%

Akathisia

11%

Headache

10%

Nausea

10%

Extrapyramidal disorder

10%

Insomnia

Vomiting

Restlessness

Constipation

Dizziness

Dyspepsia

Mania

Diarrhoea

Tremor

Hospitalisation

Aggression

Bipolar disorder

Endometrial cancer

Pulmonary embolism

Bipolar I disorder

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Cariprazine (3-6 mg/Day)

Cariprazine (6-12 mg/Day)

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CariprazineExperimental Treatment1 Intervention

Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo once daily for 8-weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cariprazine

2010

Completed Phase 3

~11050

Do I qualify?Apply below to find out

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

Atypical antipsychotics, such as Cariprazine, work by modulating dopamine and serotonin receptors in the brain. These neurotransmitters play key roles in regulating mood, behavior, and cognition. For patients with Autism Spectrum Disorder (ASD), this modulation can help manage symptoms like irritability, aggression, and repetitive behaviors. By targeting these pathways, atypical antipsychotics aim to improve behavioral outcomes and enhance the quality of life for individuals with ASD.