Study of Aripiprazole to Treat Children and Adolescents With Autism

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Bristol-Myers Squibb
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level

• Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)

• Have a guardian who is able and willing to give written informed consent

• If competent, subject able and willing to give written assent for their own participation

• If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months

• Subjects may receive other nonpharmacologic treatment including dietary treatments

Exclusion Criteria:

• Diagnosis of Rett's syndrome or Child Disintegrative Disorder

• Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks

• Previous trial of aripiprazole

• Pregnant or nursing

• Epilepsy or another significant chronic medical illness