OPT - Phase IV Long Term Maintenance Study of Aripiprazole for the Treatment of Irritability Associated With Autistic Disorder



Status:
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/16/2012
Start Date:March 2011
End Date:July 2012
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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


The purpose of this study is to determine whether pediatric subjects with irritability
associated with autistic disorder who have responded to aripiprazole treatment will
experience a relapse significantly later when continuing therapy with aripiprazole than
subjects treated with placebo


Phase 1: Single Blind/ Phase 2: Double Blind

Inclusion Criteria:

- Meets current DSM-IV-TR diagnostic criteria for autistic disorder (confirmed by the
ADI-R)

- Demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a
combination of these problems

- CGI-S score ≥ 4 AND an ABC Irritability subscale score ≥ 18 at the Screening and
Baseline Visits

- Mental age of at least 24 months

Exclusion Criteria:

- Treatment resistance to neuroleptic medication

- Lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current
diagnosis of major depressive disorder

- Diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified (NOS),
Asperger's Syndrome, Rett's Syndrome, childhood disintegrative disorder or Fragile X
Syndrome

- History of neuroleptic malignant syndrome

- Significant risk of committing suicide

- A seizure within the past year

- History of severe head trauma or stroke

- History or current evidence of any unstable medical conditions

- Weight less than 15 kg

- Known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils

- History of a clinically significant low white blood cell count or a drug-induced
leukopenia/neutropenia

- Any other medically significant abnormal laboratory test result, vital sign result or
ECG finding
We found this trial at
38
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Bristol, Tennessee 37620
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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941 York Drive DeSoto
Southwest, Texas 75115
214-477-5162
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Bloomfield Hills, Michigan 48302
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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CHapel Hill, North Carolina 27599
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Clinton, Utah 84015
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Coeur D'Alene, Idaho 83814
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Dothan, Alabama 36303
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Gainesville, Florida 32607
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Glendale, California 91204
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Gresham, Oregon 97030
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Hialeah, Florida 33012
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Las Vegas, NV
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Newton, Massachusetts 02459
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Norfolk, Virginia 23510
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Oklahoma City, Oklahoma 73116
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Oklahoma City, Oklahoma 73117
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Palo Alto, California 94306
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Pittsburgh, Pennsylvania 15213
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Richmond, Virginia 23298
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San Francisco, California 94143
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Santa Ana, California 92705
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Shreveport, Louisiana
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Smyrna, Georgia 30080
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Stony Brook, New York 11794
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Toms River, New Jersey 08755
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Tulsa, Oklahoma 74104
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Voorhees, New Jersey 08043
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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