CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Aripiprazole oral product +1 moredrug
Likely dose
Aripiprazole oral product 2 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.

Search/NCT00870727
NCT00870727Phase 3Completed
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Pharmacotherapy of Pervasive Developmental Disorders

Indiana University·interventional·Posted Mar 27, 2009·Updated Jan 2, 2019

In Brief

A Phase 3 clinical trial evaluating Aripiprazole oral product and Placebo oral capsule for Pervasive Developmental Disorder. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPervasive Developmental Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Bristol-Myers Squibb

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.3 years ago

Interventions

Aripiprazole oral productdrug

Minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment.

Placebo oral capsuledrug

Placebo will be identical in size and appearance to study drug.