Status:
COMPLETED
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Autistic Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis...
Eligibility Criteria
Inclusion
- Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
- CGI score \> = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation subscale score \> = 18 at screening and baseline (randomization)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of randomization
Exclusion
- 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, or schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00332241
Start Date
June 1 2006
End Date
April 1 2008
Last Update
December 2 2013
Active Locations (9)
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1
Marsella, Gregory
Boca Raton, Florida, United States, 33432
2
Child Neurology Associates, Pc
Atlanta, Georgia, United States, 30342
3
University Of Louisville
Louisville, Kentucky, United States, 40202
4
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302