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Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children (METHADA)

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ClinicalTrials.gov Identifier: NCT03436017
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
Attention-deficit with or without hyperactivity disorder (ADHD) is a real health public concern. No easy-use diagnosis tool are available. Metabolomic approaches has brought very usefull data in others neurological diseases like amyotrophic lateral sclerosis or autism spectrum disorder, as we had shown in previous studies. Targeting on neurotransmitter pathways involving in ADHD, metabolomic screening could help to enhance our diagnosis power to better help numerus of children. We propose to study the phenylalanine and the tyrosine pathways with a multimodal metabolomic approach, in easy-available biological fluid (blood and urine), in child or adolescent suspected of ADHD. Our objectives are: 1- to determine a specific metabolomic signature of ADHD 2- to compare the diagnostic value of this metabolomic signature with the reference methodology for ADHD diagnosis, as now practiced in our reference center for learning troubles.

Condition or disease Intervention/treatment
Adhd Other: Metabolomic approach

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identification of Biomarkers of Attention Deficit Disorder With or Without Hyperactivity (ADHD) by a Metabolomic Approach in Children
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ADHD
Patient with ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach
Other: Metabolomic approach
Biological samples (blood and urine) for a multimodal metabolomic approach

non ADHD

Patient with symptom of hyperactivity and/or attention deficiency but without ADHD diagnosis criterion.

The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach.

Other: Metabolomic approach
Biological samples (blood and urine) for a multimodal metabolomic approach




Primary Outcome Measures :
  1. ADHD metabolomic's signature of blood [ Time Frame: At baseline ]
    Detection of metabolites (phenylalanine or catécholamines) in the blood of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.

  2. ADHD metabolomic's signature of urine [ Time Frame: At baseline ]
    Detection of metabolites (phenylalanine or catécholamines) in the urine of patients with ADHD at levels significantly different from baseline levels in the general population and rates found in patients with attention deficit and / or hyperactivity disorders but that multidisciplinary assessment excludes the diagnosis of ADHD.


Biospecimen Retention:   Samples Without DNA
Blood samples Urinary samples


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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Child or adolescent with symptoms of attention disorders and / or hyperactivity, aged from 6 to 15 years old, and consulting in current care in our university hospital
Criteria

Inclusion Criteria:

  • Child or adolescent with symptoms of attention disorders and / or hyperactivity
  • aged from 6 to 15 years old

Exclusion Criteria:

  • Failure or refusal of all or part of the multidisciplinary evaluation (medical and / or neuropsychological assessments and / or biological assessments)
  • Identification of an intercurrent condition likely to have an impact on metabolomic analyzes (acute infection, fever, etc.)
  • Parents or legal guardians opposed to data processing

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): NCT03436017


Contacts
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Contact: Pierre CASTELNAU, MD-PhD 0247474757 ext +33 castelnau@univ-tours.fr
Contact: Maximilien PERIVIER, MD 0247474757 ext +33 m.perivier@chu-tours.fr

Locations
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France
University Hospital TOURS Recruiting
Tours, France, 37044
Contact: Pierre CASTELNAU, MD-PhD    0247474757 ext +33    castelnau@univ-tours.fr   
Contact: Maximilien PERIVIER, MD    0247474757 ext +33    m.perivier@chu-tours.fr   
Principal Investigator: Pierre Castelnau, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Pierre CASTELNAU, MD-PhD CHU TOURS

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03436017     History of Changes
Other Study ID Numbers: RIPH3-RNI17/METHADA
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:
adhd
metabolomics
child

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders