Blood drawing in Attention-Deficit/Hyperactivity Disorder - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Tel Aviv, Israel
    - The Unit of clinical Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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;
A consent form signed by parents or legal guardianships;

Exclusion Criteria:

A history of any other neurological or major psychiatric disorder or other significant medical problems;
No current medications;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Nachum Vaisman, Prof. (MD), Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

October 22, 2006

First Submitted That Met QC Criteria