MedTrace Logo

Thyroid Profile in Attention Deficit With Hyperactivity Disorder (ADHD)

NCT05080491 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-02-28

No results posted yet for this study

Summary

Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile.

Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry.

Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants.

Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration.

Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.

Conditions

  • Attention Deficit With Hyperactivity Disorder

Interventions

DIAGNOSTIC_TEST

immuno analysis and neuropsychological tests

A venous blood sample will be taken for assay in immuno-analysis including and for assay in chromatography with mass spectrometry. Patients will participate in computer neuropsychological tests: . Venous blood collection and the administration : the tubes are transported to the biochemistry laboratory of the University Hospital Center of Nice (CHU Nice) which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry. Administration of two neuropsychological tests on computer(Attention Network Task and Tower of London).

Sponsors & Collaborators

  • Fondation Lenval

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-01-31
Completion
2025-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05080491 on ClinicalTrials.gov