Valproate Response in Aggressive Autistic Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00065884|
Recruitment Status : Unknown
Verified June 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : August 5, 2003
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: Valproate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Valproate Response in Aggressive Autistic Adolescents|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065884
|United States, Kansas|
|Outpatient MR/Autism Clinic, University of Kansas||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Marilyn Weckbaugh, RN 913-588-1315 firstname.lastname@example.org|
|Principal Investigator:||Jessica A. Hellings, M.D.||University of Kansas|