Study of Aripiprazole to Treat Children and Adolescents With Autism
Completed · Phase 2
Conditions studied: Autistic Disorder, Asperger Syndrome, Autism Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT00619190
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 30
- Starts
- 2006-01-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2014-03-26
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina, Department of Psychiatry — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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