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

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

Study Overview

• Status: Completed
• Conditions: Asperger's Disorder; Pervasive Developmental Disorder
• Intervention / Treatment: Drug: aripiprazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46020
      • Riley Hospital, Riley Child and Adolescent Psychiatry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Clinical Global Impression(CGI)Improvement Scale.	Every 2 Weeks
The Irritability subscale of the Aberrant Behavior Checklist (ABC)	Every 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The Clinical Global Impression Severity Scale.	At baseline and endpoint
The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).	At baseline and endpoint
The Vineland Maladaptive Behavior Subscale.	At baseline and endpoint

Collaborators and Investigators

• Sponsor: Indiana University School of Medicine
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Kimberly A. Stigler, MD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Aggression; Behavioral symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities; Asperger Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 0302-24