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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oxcarbazepine Versus Placebo in Childhood Autism|
- Vineland Adaptive Behavior Scales [ Time Frame: Evaluated during Baseline and Termination ] [ Designated as safety issue: No ]
- Aberrant Behavior Checklist [ Time Frame: Bi weekly ] [ Designated as safety issue: No ]
- Clinical Global Impression Improvement Scale [ Time Frame: Once a week ] [ Designated as safety issue: No ]
- Autism Diagnostic Observation Schedule [ Time Frame: Evaluated during Baseline and Termination ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Oxcarbazepine is the active drug to be given to subjects in the experimental arm
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 morning 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 Clinical Global Improvement Scale (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 Name: Trileptal
Placebo Comparator: Sugar Pill
Patients are given either active or inactive intervention.
Other: Placebo/sugar pill
Dosage similar to active drug
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467753
|United States, New Jersey|
|Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Sherie L. Novotny, M.D||University of Medicine and Dentistry of New Jersey|