Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Kansas City, Kansas 66160


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.


Study summary:

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.


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


NCT ID:

NCT00065884


Primary Contact:

Principal Investigator
Jessica A. Hellings, M.D.
University of Kansas


Backup Contact:

N/A


Location Contact:

Kansas City, Kansas 66160
United States

Marilyn Weckbaugh, RN
Phone: 913-588-1315
Email: mweckbaugh@kumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.