Study of Aripiprazole to Treat Children and Adolescents With Autism - NCT00619190-27514 (Clinical Trial 203508)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy203508.aspx
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| City: |
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Chapel Hill |
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State:
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NC |
| Zip Code: |
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27514 |
| Conditions: |
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Autistic Disorder - Asperger Syndrome - PDD, NOS |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of North Carolina, Department of Psychiatry
Chapel Hill, NC 27514
United States
Primary Contact:
Cheryl Alderman, BA
Email: aspire@unc.edu
Phone: 1-800-708-0048 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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