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Oxcarbazepine Versus Placebo in Childhood Autism

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism

Intervention: Oxcarbazepine (Drug); Placebo/sugar pill (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Medicine and Dentistry of New Jersey

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

Summary

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.

Clinical Details

Official title: Oxcarbazepine Versus Placebo in Childhood Autism

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Vineland Adaptive Behavior Scales

Aberrant Behavior Checklist

Clinical Global Impression Improvement Scale

Autism Diagnostic Observation Schedule

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.

Eligibility

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.

Locations and Contacts

Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS, Piscataway, New Jersey 08854, United States
Additional Information

University Behavioral Healthcare official site

Starting date: April 2006
Last updated: October 25, 2013

Page last updated: August 23, 2015

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