Clinical trial NCT00198055: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asperger's Disorder
Pervasive Developmental Disorder
Keywords: Aggression
Behavioral symptoms
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Clinical Global Impression(CGI)Improvement Scale.
timeFrame: Every 2 Weeks
measure: The Irritability subscale of the Aberrant Behavior Checklist (ABC)
timeFrame: Every 2 weeks
Secondary outcomes:
measure: The Clinical Global Impression Severity Scale.
timeFrame: At baseline and endpoint
measure: The Compulsion subscale of the Children's Yale-Brown Obsessive-Compulsive(CY-BOCS).
timeFrame: At baseline and endpoint
measure: The Vineland Maladaptive Behavior Subscale.
timeFrame: At baseline and endpoint
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital, Riley Child and Adolescent Psychiatry Clinic
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Kimberly A. Stigler, MD
role: PRINCIPAL_INVESTIGATOR
References: