Investigating thyroid profiles in children with ADHD
Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)
This study is testing if children and teens with ADHD have unusual thyroid hormone levels compared to those without ADHD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT05080491 on ClinicalTrials.gov |
What this trial studies
This study aims to confirm the presence of abnormal thyroid profiles in a subgroup of children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Using chromatography with mass spectrometry, the research will analyze thyroid hormone levels in participants aged 7 to 17 years. The study will also compare these findings with results from traditional immuno-analytic assays and assess the neuropsychological characteristics of this subgroup. The research is designed to last for 30 months, with 24 months dedicated to participant inclusion and 6 months for data analysis.
Who should consider this trial
Good fit: Ideal candidates are boys and girls aged 7 to 17 years diagnosed with ADHD without any thyroid disorders.
Not a fit: Patients with known thyroid disorders or other significant psychiatric conditions like Autism Spectrum Disorder or Schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of ADHD by identifying thyroid-related factors that may influence the condition.
How similar studies have performed: While there is some observational data suggesting a link between thyroid profiles and ADHD, this approach using chromatography with mass spectrometry is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys or girls aged by 7 and 17 years old included * Diagnosed with ADHD according to DSM-5 criteria with either Inattentive predominant, Hyperactive-impulsive predominant or Combined presentations. * Scoring at least 28 (maximum value 54) on the ADHD-RS total score that is the sum of 18 items each rated on a 0-3 scale. * Scoring at least 4 (= Moderate) on the Clinical Global Impression - Severity scale * Without any clinical symptom of either hypothyroidism or hyperthyroidism * Who signed an informed consent form * Whose at least of parents (or default a legal representative) signed an informed consent form Exclusion Criteria: Known or concomitant diagnosis of Autism Spectrum Disorder according to DSM-5 criteria Known or concomitant diagnosis of Schizophrenia or Psychotic Disorder according to DSM-5 criteria Known or concomitant diagnosis of any thyroid disorder (hypothyroidism or hyperthyroidism) whatever the cause might be Known or concomitant diagnosis of any genetic condition affecting the thyroid function (e.g. Down syndrome) Intake in the last month of a psychotropic drug for: ADHD: methylphenidate, atomoxetine, dexamphetamine, lisdexamphetamine, guanfacine or clonidine. Any psychiatric disorder (antipsychotic, anxiolytics, antidepressant, etc.) Intake in the last month of a molecule affecting the thyroid function: * Any compound containing thyroid hormones * Anti-thyroid drugs: carbimazole, thiamazole, propylthiouracil and perchlorate * Any compound containing iodine * Significant application on the skin of iodized products in the last six months * Injection of water-soluble iodine contrast agents in the last 2 months or fat-soluble in the last 6 months
Where this trial is running
Nice
- Hôpitaux Pédiatriques de Nice CHU-Lenval — Nice, France (Recruiting)
Study contacts
- Study coordinator: Hervé CACI,, MD PhD
- Email: caci.h@pediatrie-chulenval-nice.fr
- Phone: 4 92 03 03 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.