Oxcarbazepine Versus Placebo in Childhood Autism - Full Text View

Purpose

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.

Condition	Intervention
Autism	Drug: Oxcarbazepine Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Oxcarbazepine Versus Placebo in Childhood Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Vineland Adaptive Behavior Scales [ Time Frame: Evaluated during Baseline and Termination ] [ Designated as safety issue: No ]
Aberrant Behavior Checklist [ Time Frame: Bi weekly ] [ Designated as safety issue: No ]
Clinical Global Impression Improvement Scale [ Time Frame: Once a week ] [ Designated as safety issue: No ]
Autism Diagnostic Observation Schedule [ Time Frame: Evaluated during Baseline and Termination ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	April 2006
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oxcarbazepine Oxcarbazepine is the active drug to be given to subjects in the experimental arm	Drug: Oxcarbazepine 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 AM 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 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 Name: Trileptal
Placebo Comparator: Sugar Pill	Other: Placebo Dosage similar to active drug

Arms

Assigned Interventions

Experimental: Oxcarbazepine

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

Drug: Oxcarbazepine

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 AM 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 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 Name: Trileptal

Placebo Comparator: Sugar Pill

Other: Placebo

Dosage similar to active drug

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

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467753

Locations

United States, New Jersey
Child and Adolescent Psychiatry at the University Behavioral Healthcare Building, UMDNJ-RWJMS
Piscataway, New Jersey, United States, 08854

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Sherie L. Novotny, M.D

University of Medicine and Dentistry New Jersey

More Information

Additional Information:

University Behavioral Healthcare official site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00467753 History of Changes
Other Study ID Numbers:	0220055339
Study First Received:	April 27, 2007
Last Updated:	March 26, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

Irritability
Functional Ability
Aggression
Mood Instability

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013