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

Pervasive Developmental Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198055
• Other study ID #: 0302-24
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 3, 2014
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• Pervasive Developmental Disorder

Intervention

Drug:
• aripiprazole
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.

Locations

Country	Name	City	State
United States	Riley Hospital, Riley Child and Adolescent Psychiatry Clinic	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Clinical Global Impression(CGI)Improvement Scale.		Every 2 Weeks	No
Primary	The Irritability subscale of the Aberrant Behavior Checklist (ABC)		Every 2 weeks	No
Secondary	The Clinical Global Impression Severity Scale.		At baseline and endpoint	No
Secondary	The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).		At baseline and endpoint	No
Secondary	The Vineland Maladaptive Behavior Subscale.		At baseline and endpoint	No