Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

PHASE4CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Autistic Disorder
Interventions
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.

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).

Trial Locations (1)

29425

Medical University of South Carolina, Charleston

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT01333072 - Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) | Biotech Hunter | Biotech Hunter