Oxcarbazepine Versus Placebo in Childhood Autism

University of Medicine and Dentistry of New Jersey

Status: Completed

Conditions: Autism

Treatments: Drug: Oxcarbazepine; Other: Placebo/sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT00467753

0220055339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Oxcarbazepine

Experimental group

Description:

Oxcarbazepine is the active drug to be given to subjects in the experimental arm

Treatment:

Drug: Oxcarbazepine

Sugar Pill

Placebo Comparator group

Description:

Patients are given either active or inactive intervention.

Treatment:

Other: Placebo/sugar pill