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Home > "V" Clinical Trials Conditions > Valproate Response in Aggressive Autistic Adolescents  Valproate Response in Aggressive Autistic Adolescents
Valproate Response in Aggressive Autistic Adolescents
For Condition: Autism
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Mental Health (NIMH)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Autism - Lives in the Kansas City area Exclusion Criteria - Psychoactive maintenance medication - Degenerative central nervous system disorder - Unstable medical illness - Seizures in the 6 months prior to study entry - History of valproate sensitivity or previous liver disease - History of ovarian cysts - Low platelet count or raised liver transaminases
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
JessicaHellings, Principal Investigator, University of Kansas
Outpatient MR/Autism Clinic, University of Kansas *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Marilyn Weckbaugh 913-588-1315
Additional Information:
Study ID Numbers: P30HD02528; K08MH01516
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065884
Other Autism Studies:
1. Secretin for the Treatment of Autism
2. Effects of CX516 on Functioning in Fragile X Syndrome and Autism
3. Synthetic Human Secretin in Children with Autism
4. Improving Attention Skills of Children with Autism
5. Longitudinal and Biological Study of Childhood Disintegrative Disorder
Related Studies:
Other Autism Clinical Trials
Other Kansas Clinical Trials
Other Kansas City Clinical Trials
Valproate Response in Aggressive Autistic Adolescents
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