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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00391495
Other study ID # TASMC-06-NV-246-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 22, 2006
Last updated June 18, 2007
Start date September 2007
Est. completion date December 2007

Study information

Verified date August 2006
Source Tel-Aviv Sourasky Medical Center
Contact Nachum Vaisman, Prof. (MD)
Phone 972-3-6974807
Email vaisman@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 13 Years
Eligibility 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;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder
  • Hyperkinesis

Intervention

Procedure:
Blood drawing


Locations

Country Name City State
Israel The Unit of Clinical Nutrition Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

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