Clinical Trial: A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

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

Official Title: A Long-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 safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).

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

Current Primary Outcome: Mean change from baseline at the final assessment in Aberrant behavior checklist Japanese version (ABC-J) Irritability subscale score [ Time Frame: Baseline, the final administration ]

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: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: June 8, 2012
Date Started: September 2012
Date Completion:
Last Updated: May 25, 2017
Last Verified: May 2017