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