Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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 3 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
      drugs risperidone and aripiprazole 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 6-17 years old with autistic disorder (AD) during a double-blind, randomized 10 week
      treatment period with either risperidone or aripiprazole. 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 5)
      a variety of single nucleotide polymorphisms related to target genes for drug disposition and
      transport, response, and tolerability. The BAART project will result in evidence-based
      guidelines for selection and monitoring of drug treatment of children and adolescents with
      AD.
    

Intervention name(s): Aripiprazole; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.; Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).
Other intervention name(s): Abilify; Risperdal
Intervention MeSH terms: Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Autistic Disorder