Oxcarbazepine Versus Placebo in Childhood Autism

Condition(s) targeted: Autism

Intervention: Oxcarbazepine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Medicine and Dentistry New Jersey

Official(s) and/or principal investigator(s):
Sherie L. Novotny, M.D, Principal Investigator, Affiliation: University of Medicine and Dentistry New Jersey

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

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.

Official title: Oxcarbazepine Versus Placebo in Childhood Autism

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

Primary outcome:

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

Detailed description: 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.

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Annie Kutlik, BA, BS, Phone: 732-235-5690, Email: kutlikam@umdnj.edu

Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS, Piscataway, New Jersey 08854, United States; Recruiting
Theodore A. Petti, M.D, MPH, Sub-Investigator
Elizabeth Roberts, PsyD, Sub-Investigator
Annie Kutlik, BA, BS, Sub-Investigator

University Behavioral Healthcare official site

Starting date: April 2006
Ending date: July 2007
Last updated: April 4, 2008