Attention-Deficit/Hyperactivity DisorderADHD_CYTONCT00391495
Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
An observational study of Attention-Deficit/Hyperactivity Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to investigate the inflammatory response in children with this disorder. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Blood drawing
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Who cannot join
- A history of any other neurological or major psychiatric disorder or other significant medical problems;
- No current medications;
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Unit of Clinical Nutrition
Tel Aviv
Nachum Vaisman, Prof., +972-524-266-596, vaisman@tasmc.health.gov.il
Nachum Vaisman, Prof.
About this study
The aim of this study is to investigate the inflammatory response in children with this disorder.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Blood drawing
- Keywords
- ADHD, Cytokines, CR-P
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startSep 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof. (MD), Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391495
- Sponsor's protocol ID
- TASMC-06-NV-246-CTIL
- Acronym
- ADHD_CYTO
- Status last verified
- Aug 2006
- First submitted
- 22 Oct 2006
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00391495
- Acronym / sponsor ID
- ADHD_CYTO / TASMC-06-NV-246-CTIL
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- ADHD, Cytokines, CR-P
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the inflammatory response in children with this disorder.
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
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (2 listed)
- A history of any other neurological or major psychiatric disorder or other significant medical problems;
- No current medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Vaisman, Prof. (MD) principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit/Hyperactivity Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof. (MD) (972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2007.