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

NCT00198055 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-06-04

No results posted yet for this study

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.

Conditions

  • Asperger's Disorder
  • Pervasive Developmental Disorder

Interventions

DRUG

aripiprazole

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 & Collaborators

Principal Investigators

  • Kimberly A. Stigler, MD · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198055 on ClinicalTrials.gov