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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 Sep 3, 2026, 7:01 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
Aug 31, 2006
Primary completion
May 31, 2009
Completion
May 31, 2009
Last update posted
Aug 3, 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 3, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00365859 live on ClinicalTrials.gov.

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