Official Title: “Oxcarbazepine Versus Placebo in Childhood Autism”

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

Subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. The subject's parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• Vineland Adaptive Behavior Scales, evaluation twice throughout the study
• Aberrant Behavior Checklist Questionnaire, evaluation biweekly
• Clinical Global Impression Improvement Scale, evaluation weekly
• Autism Diagnostic Observation Scale, evaluation twice throughout the study

Inclusion Criteria:

• Subject has autism.
• Subject is between five and seventeen years of age
• Subject is not hospitalized.

Exclusion Criteria:

• Subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder.
• Subject has displayed self-injurious behavior.
• Subject has an active seizure disorder or epilepsy.
• Subject has an unstable medical illness.
• Subject has undergone brain injury.
• Subject has a history of diabetes.
• Subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks.
• Subject has used other study drugs within the previous 30 days.
• Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Medicine and Dentistry New Jersey

Overall Clinical Trial Officials and Contacts

Sherie L. Novotny, M.D Principal Investigator University of Medicine and Dentistry New Jersey  

Overall Contact: Annie Kutlik, BA, BS 732-235-5690 kutlikam@umdnj.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00467753

Study ID Number: 0220055339

ClinicalTrials.gov Identifier: NCT00467753

Health Authority: United States: Institutional Review Board

University Behavioral Healthcare official site