Autistic Disorder | Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)
Autistic Disorder research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AripiprazoleThe 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.
Drug:RisperidoneChildren 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).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2011
Completed Date: August 2015
Phase: Phase 4
Primary Outcome: To identify phenotypic and genetic traits that predict response to aripiprazole and risperidone in Autistic Disorder
Study sponsors, principal investigator, and references
Principal Investigator: C. Lindsay DeVane, Pharm.D.
Lead Sponsor: Medical University of South Carolina