Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Aripiprazole; Risperidone
Intervention description: 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).
Intervention MeSH terms: Risperidone; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autistic Disorder

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.
    

Eligibility criteria:

        Inclusion Criteria

          -  Aged 6 to 17 years and weight of at least 15 kg

          -  Meet DSM-IV criteria for of AD, established by chart review, clinical judgment and the
             Autism Diagnostic Interview- Revised (ADI-R) criteria

          -  Clinical Global Impressions Severity (CGI-S) score of >4 (moderately ill)

          -  ABC Irritability subscale score of >18

          -  Mental age of at least 18 months

          -  If female and sexually active, must agree to an acceptable method of birth control
             during the trial

          -  Medication free or adequate washout period (2-4 weeks prior to enrollment) of
             psychoactive drugs (anticonvulsants permitted for seizure management if dosage is
             stable for 4 weeks)

          -  Parent/guardian able to read and provide informed consent.

        Exclusion Criteria

          -  Psychiatric disorder that is effectively managed by psychoactive medication (e.g.
             ADHD, MDD)

          -  Prior diagnosis or evidence of genetic or other disorder that may interfere with
             assessments (e.g. Fragile X syndrome, Fetal alcohol syndrome, history of very low
             birth weight) assessed by personal and family history, dysmorphology, and clinical
             judgment.

          -  Prior use of risperidone or aripiprazole for more than 2 weeks

          -  Seizure during the past 6 months

          -  History or evidence of a medical condition that would expose them to an undue risk of
             a significant adverse event or interfere with assessments during the trial including
             but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, hematologic
             or immunologic disease as determined by the clinical judgment of the investigator

          -  Current suicidal or homicidal risk

          -  Positive urine pregnancy test at baseline

          -  Dependent on other substances, with the exception of nicotine or caffeine