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 |
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
sites
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Click here to add this to my saved trials
Miami Children's Hospital Welcome to Miami Children
Click here to add this to my saved trials
Click here to add this to my saved trials
Stanford University School of Medicine Vast in both its physical scale and its impact on...
Click here to add this to my saved trials
University of South Florida The University of South Florida is a high-impact, global research university...
Click here to add this to my saved trials
Click here to add this to my saved trials
8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
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...
Click here to add this to my saved trials