Conditions: Autistic Disorder Asperger Syndrome Autism Spectrum Disorder
Keywords: open label aripiprazole children adolescents autism spectrum disorders
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

Detailed description:
The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

Arms:
arm 1: Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg arm 2: group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.

Interventions: intervention 1: aripiprazole
Intervention descriptions: intervention 1: aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

Protocol document: