Oxcarbazepine Versus Placebo in Childhood Autism

NCT00467753 | Completed Results DMC

• 1 other identifier: 0220055339
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Irritability; Functional Ability; Aggression; Mood Instability

Outcome Measures

Primary Outcomes (4)

• Vineland Adaptive Behavior Scales

  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.

  Evaluated during Baseline and Termination

• Aberrant Behavior Checklist

  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.

  Bi weekly

• Autism Diagnostic Observation Schedule

  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.

  Evaluated during Baseline and Termination

• Clinical Global Impression Improvement (CGI-AD)

  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.

  Administered weekly Administered weekly

Study Arms (2)

Oxcarbazepine

EXPERIMENTAL

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

Drug: Oxcarbazepine

Sugar Pill

PLACEBO COMPARATOR

Patients are given either active or inactive intervention.

Other: Placebo/sugar pill

Interventions

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.

Also known as: Trileptal

Oxcarbazepine

Placebo/sugar pill OTHER

Dosage similar to active drug

Sugar Pill

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject has autism.
• Subject is between five and seventeen years of age
• Subject is not hospitalized.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

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

Piscataway, New Jersey, 08854, United States

Location

Related Links

• University Behavioral Healthcare official site

MeSH Terms

Conditions

Autistic Disorder; Aggression

Interventions

Oxcarbazepine; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

Patients became more irritable coming off of previous medication and were unable to tolerate monotherapy with the medication.

Results Point of Contact

• Title: Sherie Novotny, MD
• Organization: UMDNJ

novotnsl@rutgers.edu

(732) @35-4119

Study Officials

• Sherie L. Novotny, M.D

  University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 13, 2021
• Results First Posted: December 16, 2013

Record last verified: 2021-01

Locations

US (1)