Clinical Trial: A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder

Brief Summary: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score [ Time Frame: baseline, 8 weeks after dosing ]

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.


Original Primary Outcome: Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score [ Time Frame: baseline, 8 weeks after dosing ]

Mean change (LOCF) from baseline in ABC-J Irritability subscale score at 8 weeks after dosing.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: June 8, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017