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Completed

NCT Number: NCT00198055

A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with Asperger's Disorder and Pervasive Developmental Disorder. This is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.

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Key information

Conditions

Asperger's Disorder Aberrant Motor Behavior in Dementia Aggression Asperger Syndrome Autism Spectrum Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Pervasive Developmental Disorder Social Behavior

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Riley Hospital, Riley Child and Adolescent Psychiatry Clinic

Indianapolis, Indiana, 46020, United States

About this study

Pervasive developmental disorders (PDD) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. Research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with PDD. After benefits of typical neuroleptics were reported in subjects with PDD's, research shifted to the atypical antipsychotics, which have been shown to be better tolerated and effective in this population. However, the atypical antipsychotics have also been associated with adverse effects. Thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with PDD's including Asperger's disorder and PDD Not Otherwise Specified (PDD NOS). We hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. We also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected QT interval (QTc) prolongation. In addition, this open-label study will serve to stimulate more definitive, controlled research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mental age of 18 months
  • Diagnosis of Asperger's Disorder or Pervasive Developmental Disorder
  • Good health overall
  • Free of all psychotropic medication for 2 weeks

Exclusion criteria

  • Weight less than 15kg
  • Subjects who have received an adequate trial of aripiprazole
  • An active seizure disorder
  • A significant medical condition
  • History of neuroleptic malignant syndrome
  • Females with positive Beta human chorionic gonadotropin(HCG) pregnancy test

Treatment and study plan

Aripiprazole

Drug

Aripiprazole 5 mg per day for 2 weeks, then can be increased to 10mg per day if tolerated for 2 weeks, then can be increased to 15 mg per day for 4 weeks.

Other names: Abilify

Primary outcomes

  1. The Clinical Global Impression(CGI)Improvement Scale.

    Time frame: Every 2 Weeks

  2. The Irritability subscale of the Aberrant Behavior Checklist (ABC)

    Time frame: Every 2 weeks

Secondary outcomes

  1. The Clinical Global Impression Severity Scale.

    Time frame: At baseline and endpoint

  2. The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).

    Time frame: At baseline and endpoint

  3. The Vineland Maladaptive Behavior Subscale.

    Time frame: At baseline and endpoint

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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