drugset / Trial / NCT01333072

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

NCT01333072

Phase 4 Completed 80 enrolled Medical University of South Carolina
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

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 3 academic centers across South Carolina. 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.

Timeline

Start
2011-07
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 15 mg
Comparator Risperidone Other / unclassified 2.5 mg
Comparator Risperidone Other / unclassified 3.5 mg

Indications