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

Primary Purpose

Asperger's Disorder, Pervasive Developmental Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asperger's Disorder focused on measuring Aggression, Behavioral symptoms

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riley Hospital, Riley Child and Adolescent Psychiatry Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

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.

Outcomes

Primary Outcome Measures

The Clinical Global Impression(CGI)Improvement Scale.
The Irritability subscale of the Aberrant Behavior Checklist (ABC)

Secondary Outcome Measures

The Clinical Global Impression Severity Scale.
The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).
The Vineland Maladaptive Behavior Subscale.

Full Information

First Posted
September 12, 2005
Last Updated
June 3, 2014
Sponsor
Indiana University School of Medicine
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00198055
Brief Title
A Study of Aripiprazole in Children and Adolescents With Aspergers and Pervasive Developmental Disorder.
Official Title
An Open-Label Study of Aripiprazole in Children and Adolescents With Autistic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asperger's Disorder, Pervasive Developmental Disorder
Keywords
Aggression, Behavioral symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Clinical Global Impression(CGI)Improvement Scale.
Time Frame
Every 2 Weeks
Title
The Irritability subscale of the Aberrant Behavior Checklist (ABC)
Time Frame
Every 2 weeks
Secondary Outcome Measure Information:
Title
The Clinical Global Impression Severity Scale.
Time Frame
At baseline and endpoint
Title
The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).
Time Frame
At baseline and endpoint
Title
The Vineland Maladaptive Behavior Subscale.
Time Frame
At baseline and endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A. Stigler, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital, Riley Child and Adolescent Psychiatry Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46020
Country
United States

12. IPD Sharing Statement

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

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