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 or CN138-179)...
Date First Received: August 15, 2006
Last Updated: July 14, 2008
Verified by: Bristol-Myers Squibb, June 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 300
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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 or CN138-179).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Outcome Measures for this Clinical Trial
Primary:
- Safety and tolerability of aripiprazole dosed flexibly from 2mg to 15mg daily throughout the study
Secondary:
- Changes in clinical global impressions throughout the study
- Changes in checklist for aberrant behavior-irritability throughout the study
- Other sub-scales and the response rate throughout the study
- Reduction in compulsive behavior throughout the study
Criteria for Participation in this Clinical Trial
Inclusion Criteria - rollover:
- Completed 8 weeks of treatment in one of the following double-blind clinical trials:
- CN138-178 or CN138-179
- No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole
Inclusion Criteria - de novo:
- Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of enrollment
Exclusion Criteria:
- Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
- Patients previously treated and not responding to aripiprazole treatment
- The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Bristol-Myers Squibb
University Of Alabama At Birmingham
Birmingham Alabama 35205 United States
Harmonex Neuroscience
Dothan Alabama 36303 United States
Southwest Autism Research And Resource Center
Phoenix Arizona 85006 United States
Stanford University School Of Medicine
Stanford California 94305 United States
University Of California-Davis Medical Center
Sacramento California 95817 United States
Sharp Mesa Vista Hospital
San Diego California 92123 United States
Peninsula Research Assoc
Rolling Hills Estate California 90274 United States
Clinical Innovations, Inc.
Costa Mesa California 92626 United States
The Children'S Hospital
Aurora Colorado 80045 United States
University Of Florida
Gainesville Florida 32611 United States
Sarkis Clinical Trials
Gainesville Florida 32607 United States
University Of South Florida
Tampa Florida 33613 United States
Marsella, Gregory
Boca Raton Florida 33432 United States
Miami Children'S Hospital
Miami Florida 33155 United States
Institute For Behavioral Medicine
Smyrna Georgia 30080 United States
Child Neurology Associates, Pc
Atlanta Georgia 30342 United States
University Of Illinois At Chicago
Chicago Illinois 60608 United States
Kansas University Medical Center
Kansas City Kansas 66160 United States
University Of Louisville
Louisville Kentucky 40202 United States
Children'S Hospital Of Michigan
Detroit Michigan 48201 United States
Neurobehavioral Medicine Group
Bloomfield Hills Michigan 48302 United States
Regions Hospital
St. Paul Minnesota 55101 United States
Children'S Mercy Hospital
Kansas City Missouri 64108 United States
Munroe-Meyer Institute
Omaha Nebraska 68198 United States
Center For Psychiatry And Behavioral Medicine
Las Vegas Nevada 89128 United States
Children'S Specialized Hosp
Toms River New Jersey 08755 United States
Seaver And New York Autism Center Of Excellence
New York New York 10029 United States
Stony Brook University School Of Medicine
Stony Brook New York 11794 United States
Richmond Behavioral Associates
Staten Island New York 10312 United States
North Shore - Long Island Jewish Health System
Bethpage New York 111714 United States
Duke Child And Family Study Center
Durham North Carolina 27710 United States
Univ Of Nc
Chapel Hill North Carolina 27599 United States
Mission Hospitals
Asheville North Carolina 28801 United States
University Hospitals Case Medical Center
Cleveland Ohio 44133 United States
The Nisonger Center
Columbus Ohio 43210 United States
Cutting Edge Research
Oklahoma City Oklahoma 73116 United States
Western Psychiatric Institute And Clinic
Pittsburgh Pennsylvania 15203 United States
Utmg/ Odyssey Research, Department Of Psychiatry
Memphis Tennessee 38105 United States
Bayou City Research, Ltd.
Houston Texas 77007 United States
Red Oak Psychiatry Associates, Pa
Houston Texas 77090 United States
Dallas Pediatric Neurology Associates
Dallas Texas 75230 United States
Neuroscience, Inc
Herndon Virginia 20170 United States
Children'S National Medical Center
Fairfax Virginia 22031 United States
Monarch Research Associates
Norfolk Virginia 23510 United States
Virginia Treatment Center For Children
Richmond Virginia 23233 United States
Pacific Institute Of Medical Sciences
Bothell Washington 98011 United States
Autism Spectrum Treatment And Research Center
Seattle Washington 98109 United States
Children'S Hospital Of Wisconsin
Milwaukee Wisconsin 53226 United States
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365859
Study ID Number: CN138-180
ClinicalTrials.gov Identifier: NCT00365859
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
