CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
aripiprazoledrug
Likely dose
aripiprazole 1mgfrom 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.

Search/NCT00619190
NCT00619190Phase 2Completed
CompareCT.gov

An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders

University of North Carolina, Chapel Hill·interventional·Posted Feb 20, 2008·Updated Mar 26, 2014

In Brief

A Phase 2 clinical trial evaluating aripiprazole for Autistic Disorder and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder, Asperger Syndrome, Autism Spectrum Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2008
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 18.4 years ago

Interventions

aripiprazoledrug

aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months