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

Indiana University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Asperger's Disorder; Pervasive Developmental Disorder

Treatments: Drug: aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00198055

0302-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Aripiprazole

Experimental group

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.

Treatment:

Drug: aripiprazole