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Inflammation in Children With Attention-Deficit/Hyperactivity Disorder (ADHD_CYTO)
This study is not yet open for participant recruitment.
Verified by Tel-Aviv Sourasky Medical Center, August 2006
First Received: October 22, 2006   Last Updated: June 18, 2007   History of Changes
Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00391495
  Purpose

The aim of this study is to investigate the inflammatory response in children with this disorder.


Condition Intervention
Attention-Deficit/Hyperactivity Disorder
Procedure: Blood drawing

U.S. FDA Resources
Study Type: Observational
Study Design: Cross-Sectional, Case Control, Prospective Study
Official Title: Inflammation in Children With Attention-Deficit/Hyperactivity Disorder

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 45
Study Start Date: September 2007
Estimated Study Completion Date: December 2007
Detailed Description:

Attention deficit-hyperactivity disorder (ADHD) is a prevalent childhood neuropsychiatric disorder, characterized by age-inappropriate and impairing levels of inattention, hyperactivity and impulsiveness. Approximately 5-10% of school-age children are affected by ADHD, and in many cases, symptoms persist into adolescence and adulthood.

Cytokines are key mediators of immune function and can be either pro-inflammatory or anti-inflammatory. Recently few studies have suggested involvement of cytokine pathways in subjects with ADHD.

Polymorphism of IL-1 receptors antagonists' alleles have been suggested in families and subjects suffering from ADHD. Moreover, a new variant of inflammatory bowel disease, another immunological based disease, was recently suggested in children with ADHD and other developmental disorders. There are no other published reports on cytokine production in children who suffer from ADHD.

  Eligibility

Ages Eligible for Study:   9 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A defined condition of ADHD according to TOVA test (TOVA score > (-1.8), Connor's questionnaire (Connor's score > 15 points) and Achenbach's questionnaire;
  2. A consent form signed by parents or legal guardianships;

Exclusion Criteria:

  1. A history of any other neurological or major psychiatric disorder or other significant medical problems;
  2. No current medications;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391495

Contacts
Contact: Nachum Vaisman, Prof. (MD) 972-3-6974807 vaisman@tasmc.health.gov.il

Locations
Israel
The Unit of Clinical Nutrition
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof. (MD) Tel-Aviv Sourasky Medical Center
Principal Investigator: Nachum Vaisman, Prof. (MD) Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Study ID Numbers: TASMC-06-NV-246-CTIL
Study First Received: October 22, 2006
Last Updated: June 18, 2007
ClinicalTrials.gov Identifier: NCT00391495     History of Changes
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
ADHD
Cytokines
CR-P

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias
Inflammation

Additional relevant MeSH terms:
Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009