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Completed

NCT Number: NCT03436017

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

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital TOURS

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolomic approach

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: METHADA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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