This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 or CN138-179)...
Date First Received: August 15, 2006
Last Updated: June 17, 2009
Verified by: Bristol-Myers Squibb, January 2009
Clinical Trial Phase: Phase 3 | Start Date: September 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder”
Condition Keyword(s):
Intervention(s):
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 or CN138-179).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Study Primary Completion Date: June 2009
Intervention(s) in this Clinical Trial
- Drug: Aripiprazole
- Tablets, Oral, 5, 10, or 15 mg, once daily, 52 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A1
- Active Abilify
Outcome Measures for this Clinical Trial
Primary Measures
- Safety and tolerability of aripiprazole dosed flexibly from 2mg to 15mg daily
- Time Frame: throughout the study
Safety Issue?: Yes
- Time Frame: throughout the study
Secondary Measures
- Changes in clinical global impressions
- Time Frame: throughout the study
Safety Issue?: No
- Time Frame: throughout the study
- Changes in checklist for aberrant behavior-irritability
- Time Frame: throughout the study
Safety Issue?: No
- Time Frame: throughout the study
- Other sub-scales and the response rate
- Time Frame: throughout the study
Safety Issue?: No
- Time Frame: throughout the study
- Reduction in compulsive behavior
- Time Frame: throughout the study
Safety Issue?: No
- Time Frame: throughout the study
Criteria for Participation in this Clinical Trial
Inclusion Criteria - rollover:
- Completed 8 weeks of treatment in one of the following double-blind clinical trials:
- CN138-178 or CN138-179
- No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole
Inclusion Criteria - de novo:
- 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)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age, inclusive, at the time of enrollment
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365859
Study ID Number: CN138-180
ClinicalTrials.gov Identifier: NCT00365859
Health Authority: United States: Food and Drug Administration
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