Oxcarbazepine Versus Placebo in Childhood Autism

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.

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
  • Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose.
• Other: Placebo
  • Dosage similar to active drug

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Oxcarbazepine
  • Oxcarbazepine is the active drug to be given to subjects in the experimental arm
• Placebo Comparator: Sugar Pill

Primary Measures

• Vineland Adaptive Behavior Scales
  • Time Frame: Evaluated during Baseline and Termination
    Safety Issue?: No
• Aberrant Behavior Checklist
  • Time Frame: Bi weekly
    Safety Issue?: No
• Clinical Global Impression Improvement Scale
  • Time Frame: Once a week
    Safety Issue?: No
• Autism Diagnostic Observation Schedule
  • Time Frame: Evaluated during Baseline and Termination
    Safety Issue?: No

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 Investigator: University of Medicine and Dentistry New Jersey Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

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