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Valproate Response in Aggressive Autistic Adolescents

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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
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Autism Drug: Valproate Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Valproate Response in Aggressive Autistic Adolescents

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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    mweckbaugh@kumc.edu   
Sponsors and Collaborators
Eunice Kennedy Shriver 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

ClinicalTrials.gov Identifier: NCT00065884     History of Changes
Other Study ID Numbers: P30HD002528 ( U.S. NIH Grant/Contract )
K08MH001516 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Additional relevant MeSH terms:
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs