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Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder

NCT01227668 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2014-05-02

Study results available
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Summary

The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Conditions

  • Irritability Associated With Autistic Disorder

Interventions

DRUG

Aripiprazole

Tablets, Oral, 2-15 mg, once daily, 13-42 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 16 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227668 on ClinicalTrials.gov