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Indianapolis, Indiana 46020


Purpose:

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 summary:

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.


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


NCT ID:

NCT00198055


Primary Contact:

Principal Investigator
Kimberly A. Stigler, MD
Indiana University School of Medicine


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46020
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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