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

Adhd Clinical Trial

— METHADA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436017
• Other study ID #: RIPH3-RNI17/METHADA
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: November 12, 2019

Study information

• Verified date: June 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhd
• Attention Deficit Disorder with Hyperactivity

Intervention

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

Locations

Country	Name	City	State
France	University Hospital TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Primary	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.	At baseline