NCT00337571

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

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: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Conditions

• Behavioral Symptoms
• Autistic Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Tablets, Oral, once daily, 8 weeks
DRUG	Placebo	Tablets, Oral, once daily, 8 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-06-16
• Last updated: 2013-12-02
• Results posted: 2009-07-23

Locations

31 sites across 1 country: United States