NCT00065884

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

August 1, 2003

Last Update Submit

June 23, 2005

Conditions

Autism

Keywords

Adolescents

Interventions

ValproateDRUG

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Autism
  • Lives in the Kansas City area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient MR/Autism Clinic, University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Jessica A. Hellings, M.D.

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

US(1)