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Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

NCT00870727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-01-02

Study results available
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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.

Conditions

  • Pervasive Developmental Disorder

Interventions

DRUG

Aripiprazole oral product

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

DRUG

Placebo oral capsule

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Kimberly A. Stigler, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-03-31
Completion
2015-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00870727 on ClinicalTrials.gov