We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammation in Children With Attention-Deficit/Hyperactivity Disorder (ADHD_CYTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00391495
Recruitment Status : Unknown
Verified August 2006 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2006
Last Update Posted : June 19, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The aim of this study is to investigate the inflammatory response in children with this disorder.

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

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.


Study Design

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
Study Start Date : September 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391495


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

Locations
Israel
The Unit of Clinical Nutrition Not yet recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof.    +972-524-266-596    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof. (MD) Tel-Aviv Sourasky Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00391495     History of Changes
Other Study ID Numbers: TASMC-06-NV-246-CTIL
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: June 19, 2007
Last Verified: August 2006

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

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