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 ScalesAberrant 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
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