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

Completed

• Conditions: Adhd
• Interventions: Other: Metabolomic approach

• Registration Number: NCT03436017
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study Start: 2018-01-29
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non ADHD	Metabolomic approach	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.
ADHD	Metabolomic approach	Patient with ADHD diagnosis criterion. The aim is the identification of Biomarkers of ADHD by a Metabolomic Approach

Primary Outcome Measures

Name	Time	Method
ADHD metabolomic's signature of blood	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.
ADHD metabolomic's signature of urine	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.

Trial Locations

Locations (1)

University Hospital TOURS; 🇫🇷 Tours, France