At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 16, 2006·Updated May 13, 2026
In Brief
A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Behavioral Symptoms and Autistic Disorder. Completed, enrolled 218 participants across 31 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBehavioral Symptoms, Autistic Disorder
CountriesUnited States
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedJun 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedJun 16, 2006
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.0 years ago
Interventions
Aripiprazoledrug
Tablets, Oral, once daily, 8 weeks
Placebodrug
Tablets, Oral, once daily, 8 weeks