At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 98 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Aripiprazole 15 mgfrom 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, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 1, 2006·Updated May 13, 2026
In Brief
A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Autistic Disorder. Completed, enrolled 98 participants across 9 sites.
Detailed Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesUnited States
CollaboratorsOtsuka America Pharmaceutical
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2006
Enrollment StartJun 2006
Primary CompletionApr 2008
TodayJul 2026
First PostedJun 1, 2006
Enrollment StartJun 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.1 years ago
Interventions
Aripiprazoledrug
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
Placebodrug
Tablets, Oral, once daily, 8 weeks