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:
Behavioral Symptoms
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 with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of au...
Eligibility Criteria
Inclusion
- 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).
- CGI score \> = 4 AND an 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, 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00337571
Start Date
June 1 2006
End Date
June 1 2008
Last Update
December 2 2013
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Harmonex Neuroscience
Dothan, Alabama, United States, 36303
3
Southwest Autism Research And Resource Center
Phoenix, Arizona, United States, 85006
4
Clinical Innovations, Inc.
Huntington Beach, California, United States, 92647