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Interagency Autism Coordinating Committee (IACC)
Autism Research Database
Office of Autism Research Coordination (OARC)
 
Project Element Element Description

Project Title

Project Title

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

Principal Investigator

Principal Investigator

Devane, C. Lindsay

Description

Description

The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves three academic centers across South Carolina, with expertise in phenotyping patients with autistic spectrum disorders, assessing patient response in clinical trials, and expertise in pharmacogenomic research. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments, for which evidence-based support is sparse. BAART will assess predictors of efficacy, tolerability, and safety in 200 children five to seventeen years old with autistic disorder (AD) during a double-blind, randomized ten week treatment period with either risperidone or aripiprazole following a two-week single-blind placebo period. Responders who complete the study may continue with medication treatment for three months. Factors considered will include 1) psychiatric history; 2) symptom response; 3) psychosocial support; 4) measures of tolerability; 5) serum prolactin and brain-derived neurotrophic factor concentration; and 6) a variety of single nucleotide polymorphisms related to target genes for drug disposition and transport, response, and tolerability. Data analysis will allow assessment of gender, race, and multiple biomarkers for their predictive value on the clinical course and outcome to treatment with two widely used pharmacologic interventions for AD. The BAART project will result in evidence-based guidelines for selection and monitoring of drug treatment of children and adolescents with AD.

Funder

Funder

National Institutes of Health

Fiscal Year Funding

Fiscal Year Funding

634243

Current Award Period

Current Award Period

2010-2015

Strategic Plan Question

Strategic Plan Question

Question 4: Which Treatments And Interventions Will Help?

Strategic Plan Objective

Strategic Plan Objective

Yellow dot: Objective has some degree of funding, but less than the recommended amount. 4SF. Launch randomized controlled trials of interventions including biological signatures and other measures to predict response, and monitor quality of life and functional outcomes in each of the following groups: o Five trials in infants and toddlers by 2013. IACC Recommended Budget: $30,000,000 over 5 years. o Three trials in school-aged children and/or adolescents by 2013. IACC Recommended Budget: $18,000,000 over 5 years. o Three trials in adults by 2014. IACC Recommended Budget: $18,000,000 over 5 years.

Project Link

Project Link

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) (External web link)

Institution

Institution

Medical University of South Carolina

State/Country

State/Country

South Carolina

Project Number

Project Number

5R01HD062550-03

Federal or Private?

Federal or Private?

Federal

Received ARRA Funding?

Received ARRA Funding?

No

History/Related Projects

History/Related Projects

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) | 651465 | 2011 | 5R01HD062550-02

 
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