1. Pharmacotherapy of Autism Spectrum Disorder: Results from the Randomized BAART Clinical Trial
- Author
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John E. Bragg, Anne Kinsman, John E. Williams, Frampton Gwynette, C. Lindsay DeVane, Eve G. Spratt, Ruth K. Abramson, Nancy R. Powers, Craig A. Stuck, Markus J.P. Kruesi, Laura A. Carpenter, Shelley T. Sherk, Alicia G. Hall, Catherine C. Bradley, Jennifer L. Donovan, Sarah Raven, Mark E. Geesey, and Jane M. Charles more...
- Subjects
0301 basic medicine ,Male ,medicine.medical_specialty ,Adolescent ,Autism Spectrum Disorder ,030106 microbiology ,Aripiprazole ,030204 cardiovascular system & hematology ,Placebo ,Weight Gain ,Article ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Adverse effect ,Child ,Risperidone ,business.industry ,medicine.disease ,Clinical trial ,Treatment Outcome ,Tolerability ,Autism ,Female ,business ,medicine.drug ,Antipsychotic Agents - Abstract
STUDY OBJECTIVE: The objective of this trial—Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)—was to provide support and guidance for an evidence-based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety. DESIGN: Randomized, double-blind, parallel-group study. SETTING: Three academic medical centers and a single private pediatric practice. PATIENTS: Eighty children or adolescents (aged 6–17 years) with autistic disorder were enrolled, and 61 patients were randomized to study drug. Of those patients, 51 completed the 10-week trial, and 31 completed an optional 12-week blinded extension phase. INTERVENTION: All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug dosing followed United States Food and Drug Administration (FDA) labeling, and weekly dosage adjustments were allowed until week 4; patients were then maintained on a fixed dose for 6 additional weeks. MEASUREMENTS AND MAIN RESULTS: Safety, physical, and psychological assessments were recorded weekly or every two weeks. No significant differences in severity of illness between the aripiprazole and risperidone groups were noted at baseline. All patients significantly improved on the Aberrant Behavior Checklist irritability subscale after one week and continued for the remaining 9 weeks and the extension phase. Improvement was greatest in the risperidone group at every assessment period and was statistically significantly better than that in the aripiprazole group at weeks 3 and 6 (p more...
- Published
- 2019