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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01227668

Public ClinicalTrials.gov record NCT01227668. 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 Nov 6, 2026, 1:23 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Safety and Efficacy of Aripiprazole in the Long-term Maintenance Treatment of Pediatric Patients With Irritability Associated With Autistic Disorder

Brief summary

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

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.

Study identification

NCT ID
NCT01227668
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
215 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
Mar 7, 2011 (Actual)
Primary completion
Jun 20, 2012 (Actual)
Completion
Jun 20, 2012 (Actual)
Last update posted
Nov 3, 2026

2011 – 2012

United States locations

U.S. sites
38
U.S. states
23
U.S. cities
36
Facility City State ZIP Site status
Harmonex Neuroscience Research, Inc Dothan Alabama 36303 —
Southwest Autism Research And Resource Center Phoenix Arizona 85006 —
Clinical Innovations, Inc. Costa Mesa California 92626 —
Behavioral Research Specialists, Llc Glendale California 91206 —
Abbey Neuropsychology Clinic Palo Alto California 94306 —
Ucsf - Lppi San Francisco California 94143 —
Stanford University School Of Medicine Stanford California 94305 —
Children'S National Medical Center Washington D.C. District of Columbia 20010 —
Sarkis Clinical Trials Gainesville Florida 32607 —
Palm Springs Research Institute Hialeah Florida 33012 —
Florida Clinical Research Center, Llc Maitland Florida 32751 —
Miami Children'S Hospital Miami Florida 33155 —
University Of South Florida Tampa Florida 33613 —
Institute For Behavioral Medicine, Llc Smyrna Georgia 30080 —
Kootenai Behavioral Health Center Coeur d'Alene Idaho 83814 —
Kosair Charities Pediatric Clinical Research Unit Louisville Kentucky 40202 —
Lsu Health Sciences Center Shreveport Louisiana 71103 —
Neurocare, Inc. Newton Massachusetts 02459 —
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302 —
Center For Psychiatry And Behavioral Medicine, Inc Las Vegas Nevada 89128 —
Clinical Research Center Of New Jersey Gibbsboro New Jersey 08026 —
Children'S Specialized Hosp Toms River New Jersey 08755 —
Stony Brook University School Of Medicine Stony Brook New York 11794 —
Unc Chapel Hill Chapel Hill North Carolina 27517 —
Cleveland Clinic Cleveland Ohio 44104 —
University Hospitals Case Medical Center Cleveland Ohio 44106 —
The Ohio State University Nisonger Center Columbus Ohio 43210 —
Cutting Edge Research Group Oklahoma City Oklahoma 73116 —
Ou Physician'S Child Study Center Oklahoma City Oklahoma 73117 —
Tulsa Clinical Research, Llc Tulsa Oklahoma 74104 —
Cyn3rgy Research Gresham Oregon 97030 —
Drexel University College Of Medicine Philadelphia Pennsylvania 19124 —
Western Psychiatric Institute And Clinic Pittsburgh Pennsylvania 15203 —
Holston Medical Group Kingsport Tennessee 37660 —
Insite Clinical Research DeSoto Texas 75115 —
Ericksen Research And Development Clinton Utah 84015 —
Childrens Specialty Gr., Pllc Norfolk Virginia 23510 —
Virginia Treatment Center For Children Richmond Virginia 23298 —

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 NCT01227668, 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 Nov 3, 2026 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01227668 live on ClinicalTrials.gov.

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