Autism Clinical Trial
Official title:
A Prospective Open-Label Trial of Aripiprazole Monotherapy in the Autism Spectrum Disorders (ASD)
Verified date | December 2010 |
Source | Cambridge Health Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from ASD over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Males and Females ages 6-17 - A diagnosis of Autism, Asperger's Disorder, or PDD NOS - Medically healthy - Ability to give assent - Significant tantrums, aggression, self-injurious behavior and/or agitation by achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability subscale and a score of moderate or higher on the Clinical Global Impressions-Severity Scale. Exclusion Criteria: - Co-morbid serious mental illness. - IQ <50, based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence (WASI, 1999 Harcourt Assessment, Inc.). - Significant active medical and/or neurological illness. - Subjects that require other psychotropic medications such as antidepressants, mood stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic medications in order to maintain clinical stability. - Active substance abuse/dependence based upon history and urine toxicology screen. - Inability to have blood drawn at baseline and termination visits. - Known allergy or hypersensitivity to aripiprazole or its ingredients. - Patients clinically stable on current medications. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cambridge Health Alliance | Medford | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cambridge Health Alliance | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impressions-Improvement | Weekly | No | |
Primary | Aberrant Behavior Checklist-Irritability subscale | Weekly | No |
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