CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Aripiprazoledrug
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.

Search/NCT00308074
NCT00308074Phase 2Completed
CompareCT.gov

A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)

Cambridge Health Alliance·interventional·Posted Mar 29, 2006·Updated Feb 15, 2017

In Brief

A Phase 2 clinical trial evaluating Aripiprazole for Autism and 2 related conditions. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism, Asperger's Disorder, Pervasive Developmental Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 29, 2006
Enrollment StartFeb 1, 2006
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.3 years ago

Interventions

Aripiprazoledrug

open-label, flexible-dosing