Clinical trial NCT00467753: Oxcarbazepine Versus Placebo in Childhood Autism
Official title: Oxcarbazepine Versus Placebo in Childhood Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Irritability
Functional Ability
Aggression
Mood Instability
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2007-05-01
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Vineland Adaptive Behavior Scales
timeFrame: Evaluated during Baseline and Termination
measure: Aberrant Behavior Checklist
timeFrame: Bi weekly
measure: Autism Diagnostic Observation Schedule
timeFrame: Evaluated during Baseline and Termination
measure: Clinical Global Impression Improvement (CGI-AD)
timeFrame: Administered weekly Administered weekly
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Sherie L. Novotny, M.D
role: PRINCIPAL_INVESTIGATOR
References: