Safety and Efficacy of Aripiprazole in the Long-Term MaintenanceTreatment ofPediatric Subjects with Irritability Associated with Autistic Disorder - Aripiprazole in Autism

Otsuka Pharmaceutical Development & Commercialization, Inc0 个研究点目标入组 215 人开始时间: 2017年4月7日最近更新: 2017年4月18日

适应症

试验速览

暂无简介。

•Male or female subjects 6 to
•17 years of age at the time of the baseline visit meeting Diagnostic and
•Statistical Manual
•of Mental Disorders-Fourth Edition, Text Revision (DSM-IV-TR)
•diagnostic criteria for
•autistic disorder and demonstrating behaviors such as tantrums,
•aggression, self-injurious
•behavior, or a combination of these problems were included in the trial.
•The diagnosis of
•AD was to be confirmed by the Autism Diagnostic Interview-Revised.
•Subjects were to
•have Clinical Global Impressions-Severity Scale (CGI-S) scores = 4 AND
•Subscale score = 18 at the screening and baseline visits and to have a mental age of at
•least 24 months, as assessed by the investigators.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 215
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

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