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Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

NCT00337571 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-05-13

Study results available
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Summary

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

Conditions

  • Behavioral Symptoms
  • Autistic Disorder

Interventions

DRUG

Aripiprazole

Tablets, Oral, once daily, 8 weeks

DRUG

Placebo

Tablets, Oral, once daily, 8 weeks

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-01
Primary Completion
2008-06-01
Completion
2008-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00337571 on ClinicalTrials.gov