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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00365859

Public ClinicalTrials.gov record NCT00365859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 6:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Study identification

NCT ID
NCT00365859
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
330 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 1, 2006 (Actual)
Primary completion
Jun 1, 2009 (Actual)
Completion
Jun 1, 2009 (Actual)
Last update posted
Aug 4, 2026

2006 – 2009

United States locations

U.S. sites
55
U.S. states
26
U.S. cities
52
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35203 —
Harmonex Neuroscience Dothan Alabama 36303 —
Southwest Autism Research and Resource Center Phoenix Arizona 85006 —
Univ of Arizona Tucson Arizona 85724-5002 —
Clinical Innovations, Inc Costa Mesa California 92626 —
Peninsula Research Assoc Rolling Hills Estates California 90274 —
University Of California-Davis Health Science Center Sacramento California 95817 —
Sharp Mesa Vista Hospital San Diego California 92123 —
Stanford University School Of Medicine Stanford California 94305-5719 —
The Children's Hospital Aurora Colorado 80045 —
Offices of Gregory Marsella, MD, PA Boca Raton Florida 33432 —
Sarkis Clinical Trials Gainesville Florida 32607 —
University of Florida Gainesville Florida 32611 —
Miami Children's Hospital Miami Florida 33155 —
University of South Florida Tampa Florida 33613 —
Children's Developmental Center Winter Park Florida 32792 —
Child Neurology Associates, PC Atlanta Georgia 30342 —
Institute For Behavioral Medicine Smyrna Georgia 30080-6342 —
University of Illinois at Chicago Chicago Illinois 60608 —
Kansas University Medical Center Kansas City Kansas 66160 —
University of Louisville Louisville Kentucky 40202 —
Massachusetts General Hospital Cambridge Massachusetts 02138 —
Cambridge Health Alliance Cambridge Massachusetts 02139 —
Ladders Clinic Wellesley Massachusetts 02481 —
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302 —
Children's Hospital Of Michigan Detroit Michigan 48201 —
Regions Hospital Saint Paul Minnesota 55101 —
Children's Mercy Hospital and Clinics Kansas City Missouri 64108-4619 —
Munroe-Meyer Institute Diagnostic Center Omaha Nebraska 68198-5380 —
Center for Psychiatry and Behavioral Medicine Las Vegas Nevada 89128 —
Children's Specialized Hospital Toms River New Jersey 08755 —
North Shore - Long Island Jewish Health System Bethpage New York 11714 —
Seaver and New York Autism Center of Excellence New York New York 10029 —
Richmond Behavioral Associates Staten Island New York 10312 —
SUNY at Stony Brook - School of Medicine Stony Brook New York 11794-8790 —
Mission Hospitals - Mission Children's Clinics Asheville North Carolina 22801 —
University of NC Chapel Hill North Carolina 27599-7160 —
Duke Child and Family Study Center Durham North Carolina 27710 —
University of Cincinnati Cincinnati Ohio 45267-0559 —
University Hospitals of Cleveland Cleveland Ohio 44106 —
The Nisonger Center Columbus Ohio 43210 —
Cutting Edge Research Oklahoma City Oklahoma 73116 —
Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania 15203 —
UT Medical Group, Department Of Psychiatry Memphis Tennessee 38105 —
Dallas Pediatric Neurology Associates Dallas Texas 75230 —
Bayou City Research, Ltd. Houston Texas 77007 —
Red Oak Psychiatry Associates, PA Houston Texas 77090 —
North San Antonio Healthcare Associates San Antonio Texas 78218 —
Children's National Medical Center Fairfax Virginia 22031 —
Neuroscience, Inc Herndon Virginia 20170 —
Monarch Research Associates Norfolk Virginia 23510 —
Virginia Treatment Center For Children Richmond Virginia 23298 —
Pacific Institute of Medical Sciences Bothell Washington 98034 —
Autism Spectrum Treatment and Research Center Seattle Washington 98109 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00365859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00365859 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →