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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asperger's Disorder, Pervasive Developmental Disorder

Intervention / Treatment
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* Drug: aripiprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole<br>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<br>* 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.<br>* Other names: Abilify;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aggression, Behavioral symptoms