Trial Profile

A multicenter double-blind, randomized, placebo-controlled, parallel-group study with three fixed doses of aripiprazole in the treatment of children and adolescents with autistic disorder (AD)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 04 Dec 2013

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At a glance

Drugs Aripiprazole (Primary)
Indications Autistic disorder
Focus Adverse reactions; Registrational; Therapeutic Use
Sponsors Bristol-Myers Squibb; Otsuka Pharmaceutical Development & Commercialization

21 Nov 2009 Based on data from this and another phase III study (CTP 700015397), the U.S. FDA has approved aripiprazole for the treatment of irritability associated with autistic disorder in paediatric patients (ages 6 to 17 years).
01 Oct 2009 Results published in the Journal of the American Academy of Child and Adolescent Psychiatry.
18 May 2009 Results presented at the 162nd Annual Meeting of the American Psychiatric Association (APA 2009).

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