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CompletedNCT03436017METHADAUpdated Jun 24, 2021

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

An observational study in Adhd, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
89
Ages
6 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adhd

Keywords

  • adhd
  • metabolomics
  • child
03

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
89 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • ADHD

    Patient with ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach

    Other: 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

Interventions

  • OtherMetabolomic approach

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

05

What researchers measure

Primary outcomes

  1. ADHD metabolomic's signature of blood

    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.

    Time frame: At baseline

  2. ADHD metabolomic's signature of urine

    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.

    Time frame: At baseline

06

Study locations

1 site
  • University Hospital TOURS
    Tours, 37044, France
07

Registry details

Key details

Study ID
NCT03436017
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Jan 29, 2018
Primary completion
Nov 12, 2019
Completion
Nov 12, 2019
Last update
Jun 24, 2021

Study contacts

Pierre CASTELNAU, MD-PhD
principal investigator · CHU Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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