Asperger's Disorder, Pervasive Developmental Disorder
Conditions
Keywords
Aggression, Behavioral symptoms
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.
Interventions
DRUGaripiprazole
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.
Sponsors
Bristol-Myers Squibb
Indiana University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed