Cariprazine for Autism Spectrum Disorder
Trial Summary
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 doctors to understand how your current medications might interact with the trial.
What data supports the effectiveness of the drug Cariprazine for Autism Spectrum Disorder?
Is Cariprazine safe for use in humans?
Cariprazine has been studied for safety in both adults and children, showing that it is generally well tolerated. Common mild or moderate side effects include weight gain, increased appetite, dizziness, and nasal congestion, with some reports of movement-related symptoms that resolved without stopping the treatment.23456
How is the drug Cariprazine unique for treating Autism Spectrum Disorder?
Cariprazine is unique because it is a dopamine D3-preferring D3/D2 receptor partial agonist, which means it works by balancing certain brain chemicals differently than other treatments. It is being explored for Autism Spectrum Disorder (ASD) as there are currently no approved medications specifically for the core social and behavioral deficits in ASD.12345
What is the purpose of this trial?
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.
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
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.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral capsules or oral solution of cariprazine or placebo once daily for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cariprazine
- Placebo
Cariprazine is already approved in United States for the following indications:
- 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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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