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NCT00065884 Clinical Trial

Valproate Response in Aggressive Autistic Adolescents

Autism Clinical Trial

Official title:
Valproate Response in Aggressive Autistic Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00065884
Other study ID # P30HD002528
Secondary ID K08MH001516
Status Recruiting
Phase Phase 3
First received August 1, 2003
Last updated June 23, 2005

Study information
Verified date June 2003
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 21 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Valproate

Locations
Country Name City State
United States Outpatient MR/Autism Clinic, University of Kansas Kansas City Kansas

Sponsors (2)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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