Oxcarbazepine Versus Placebo in Childhood Autism

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00467753
First received: April 27, 2007
Last updated: October 25, 2013
Last verified: March 2013
  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/sugar pill

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:


Further study details as provided by Rutgers, The State University of 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 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 Name: Trileptal
Placebo Comparator: Sugar Pill
Patients are given either active or inactive intervention.
Other: Placebo/sugar pill
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of New Jersey
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Sherie L. Novotny, M.D University of Medicine and Dentistry of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00467753     History of Changes
Other Study ID Numbers: 0220055339
Study First Received: April 27, 2007
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of 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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014