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| Sponsors and Collaborators: |
National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00065884 |
Purpose
This study will examine the effect of valproate, a medication used to treat seizures and bipolar disorder, on aggressive behavior in children and adolescents with autism.
| Condition | Intervention | Phase |
|
Autism |
Drug: Valproate |
Phase III |
| MedlinePlus related topics: | Autism |
| ChemIDplus related topics: | Divalproex sodium Valproate Sodium Valproic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | Valproate Response in Aggressive Autistic Adolescents |
| Estimated Enrollment: | 30 |
Autism is a complex biological disorder that generally lasts throughout a person’s life. It starts before age three and causes delays or problems with many different ways in which a person develops or grows. Some people with autism become very aggressive and can hurt others or themselves. This study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcg/ml than to placebo. The study will also assess the safety of valproate in autistic adolescents. This represents the first double-blind study of valproate in mentally retarded/developmentally delayed populations.
Participants in this study will undergo DSM-IV evaluation, the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule, and baseline blood tests. After baseline screening, all participants will be given a placebo for 1 week. Participants will then be randomized to receive either valproate or placebo for 8 weeks. Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind. The Aberrant Behavior Check-list-Community (ABC-C) irritability subscale will be the primary measure; the Overt Aggression Scale (OAS), ABC-C hyperactivity subscale, Clinical Global Impressions (CGI) problem severity, Self-Injurious Behavior Questionnaire (SIB-Q), and a valproate side effects checklist will be secondary measures.
Eligibility
| Ages Eligible for Study: | 6 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Kansas | |||||
| Outpatient MR/Autism Clinic, University of Kansas | Recruiting | ||||
| Kansas City, Kansas, United States, 66160 | |||||
| Contact: Marilyn Weckbaugh, RN 913-588-1315 mweckbaugh@kumc.edu | |||||
| National Institute of Child Health and Human Development (NICHD) |
| National Institute of Mental Health (NIMH) |
| Principal Investigator: | Jessica A. Hellings, M.D. | University of Kansas |
More Information
| Study ID Numbers: | P30HD02528, K08MH01516 |
| First Received: | August 1, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00065884 |
| Health Authority: | United States: Federal Government |
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