NCT00619190

Study of Aripiprazole to Treat Children and Adolescents With Autism

An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 30 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autistic Disorder
• Asperger Syndrome
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	aripiprazole	aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

Timeline

• Start date: 2006-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-02-20
• Last updated: 2014-03-26
• Results posted: 2014-03-26

Locations

1 site across 1 country: United States