Valproate Response in Aggressive Autistic Adolescents
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 21 |
| Updated: | 4/2/2016 |
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.
bipolar disorder, on aggressive behavior in children and adolescents with autism.
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.
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.
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
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