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”

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

Primary Measures

• Safety and tolerability of aripiprazole dosed flexibly from 2mg to 15mg daily
  • Time Frame: throughout the study
    Safety Issue?: Yes

Secondary Measures

• Changes in clinical global impressions
  • Time Frame: throughout the study
    Safety Issue?: No
• Changes in checklist for aberrant behavior-irritability
  • Time Frame: throughout the study
    Safety Issue?: No
• Other sub-scales and the response rate
  • Time Frame: throughout the study
    Safety Issue?: No
• Reduction in compulsive behavior
  • Time Frame: throughout the study
    Safety Issue?: No

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

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

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

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm