Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Autistic Disorder |
Drug: Aripiprazole Drug: Risperidone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Biomarkers in Autism of Aripiprazole and Risperidone Treatment |
- To identify phenotypic and genetic traits that predict response to aripiprazole and risperidone in Autistic Disorder [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile.
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Risperidone
Atypical antipsychotic
|
Drug: Risperidone
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 Name: Risperdal
|
|
Active Comparator: Aripiprazole
Atypical antipsychotic
|
Drug: Aripiprazole
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.
Other Name: Abilify
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Stacey Wilson | 843-792-0384 | wilstac@musc.edu |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: C. Lindsay DeVane, PharmD | |
| Principal Investigator: | C. Lindsay DeVane, Pharm.D. | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Lindsay DeVane, Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01333072 History of Changes |
| Other Study ID Numbers: | R01HD062550-01A1 |
| Study First Received: | September 20, 2010 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
Autistic Disorder |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Risperidone Aripiprazole Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on June 18, 2013