Valproate Response in Aggressive Autistic Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Autism

Keywords

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Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Valproate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jessica A. Hellings, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

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Outpatient MR/Autism Clinic, University of Kansas

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Marilyn Weckbaugh, RN

Role: primary

Other Identifiers

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K08MH001516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30HD002528