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Completed

NCT Number: NCT00467753

Oxcarbazepine Versus Placebo in Childhood Autism

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.

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Key information

Conditions

Autism Aberrant Motor Behavior in Dementia Aggression Autism Spectrum Disorder Autistic Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Social Behavior

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS

Piscataway, New Jersey, 08854, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxcarbazepine

Drug

Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose.

Other names: Trileptal

Placebo/sugar pill

Other

Dosage similar to active drug

Primary outcomes

  1. Vineland Adaptive Behavior Scales

    Time frame: Evaluated during Baseline and Termination

    The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.

  2. Aberrant Behavior Checklist

    Time frame: Bi weekly

    Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.

  3. Autism Diagnostic Observation Schedule

    Time frame: Evaluated during Baseline and Termination

    The Autism Diagnostic Observation Schedule is primarily used as a diagnostic tool providing a standardized assessment for observation of social and communicative behavior in children and adults. It is composed of four modules for assessing children/adults of varying language ability (Module 1 for nonverbal individuals, to Module 4 fluent individuals). The instrument provides a series of structured and semi-structured presses for social interaction and communication, which are then scored. The scores are 0 (no behavior) to 3 (markedly abnormal). Subcategories are Language/communication, 8 scores, Social interaction, 12 scores, Stereotyped Behavior/restricted interests, 4 scores and Play, 2 scores, as well as other behavior, 3 scores. The maximum score is 87, minimum is 0, with cutoff scores to determine diagnosis. Higher scores indicate a more severe behavioral disorder.

  4. Clinical Global Impression Improvement (CGI-AD)

    Time frame: Administered weekly Administered weekly

    Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes.

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
May 1, 2007
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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