Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) (BAART)
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|ClinicalTrials.gov Identifier: NCT01333072|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: Aripiprazole Drug: Risperidone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Biomarkers in Autism of Aripiprazole and Risperidone Treatment|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: 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
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
- To identify phenotypic and genetic traits that predict response to aripiprazole and risperidone in Autistic Disorder [ Time Frame: 10 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333072
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||C. Lindsay DeVane, Pharm.D.||Medical University of South Carolina|