ADHD - Attention Deficit Disorder With Hyperactivity, Chronic Pain, Fibromyalgia (FM)
Conditions
Brief summary
The overall objective of the research project presented here is to assess the prevalence of fibromyalgia in patients being treated for ADHD, the prevalence of ADHD in patients being treated for fibromyalgia, and the neurobiological correlates of ADHD-fibromyalgia comorbidity.
Interventions
BIOLOGICALSamples
Blood and urine samples including metabolomic analyses.
OTHERQuestionnaires
Completing self-assessment questionnaires
OTHERSensitivity to mechanical pain
Assessment of sensitivity to mechanical pain (by using the Von Frey monofilament test)
Sponsors
University Hospital, Tours
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
For patients with fibromyalgia : * Men or women aged 18 or over * Diagnosis of fibromyalgia * Affiliated with a social security scheme * Having signed an informed consent form For patients with ADHD treated with methylphenidate * Men or women aged 18 or over * ADHD diagnosis * Current treatment with extended-release methylphenidate for at least 1 month, with stable dosage for at least 2 weeks * Affiliated with a social security scheme * Having signed an informed consent form For patients with ADHD but not treated with methylphenidate * Men or women aged 18 or over * ADHD diagnosis * Affiliated with a social security scheme * Having signed an informed consent form
Exclusion criteria
* For patients with fibromyalgia: existence of another condition explaining chronic pain * Severe cognitive impairment * Difficulties in understanding self-administered questionnaires * Difficulties in assessing pain intensity * Acute psychiatric disorder impacting the validity of self-report questionnaire data collection * Inability to take biological samples * Persons covered by Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to legal protection measures: guardianship or curatorship).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment | Baseline | Comparison of the observed prevalence of fibromyalgia (as assessed by the ACR diagnostic criteria) among patients with ADHD (as assessed by the DIVA-5 diagnostic interview) and no prior methylphenidate treatment versus the theoretical prevalence of fibromyalgia in the overall French population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with fibromyalgia among patients with ADHD and a current methylphenidate treatment | Baseline | Comparison of the observed prevalence of fibromyalgia (as assessed by the ACR diagnostic criteria) among patients with ADHD (as assessed by the DIVA-5 diagnostic interview) and a current methylphenidate treatment versus the theoretical prevalence of fibromyalgia in the French overall population |
| Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD | Baseline | Plasma and urine levels of different cytokines (IFN-gamma, IL-1B, IL-6, IL10, IL-13, IL-17, TNF-alpha), as assessed by metabolomic analyses (high-performance liquid chromatography) |
| Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia | Baseline | Plasma and urine levels of different cytokines (IFN-gamma, IL-1B, IL-6, IL10, IL-13, IL-17, TNF-alpha), as assessed by metabolomic analyses (high-performance liquid chromatography) |
| Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD | Baseline | Plasma and urine levels of different cytokines (IFN-gamma, IL-1B, IL-6, IL10, IL-13, IL-17, TNF-alpha), as assessed by metabolomic analyses (high-performance liquid chromatography) |
| Comparison of the levels of neuro-inflammation biomarkers (i.e., tryptophane derivatives, short carbon chain fatty acids, lipidomic profile) between patients with fibromyalgia without ADHD, | Baseline | Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses |
| Comparison of the levels of neuro-inflammation biomarkers (i.e., tryptophane derivatives, short carbon chain fatty acids, lipidomic profile) between patients with ADHD without fibromyalgia | Baseline | Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses |
| Comparison of the levels of neuro-inflammation biomarkers (i.e., tryptophane derivatives, short carbon chain fatty acids, lipidomic profile) between patients with fibromyalgia with ADHD | Baseline | Plasma and urine levels of tryptophane derivatives short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses |
| Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD | Baseline | Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography) |
| Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia | Baseline | Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography) |
| Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD | Baseline | Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography) |
Contacts
CONTACTPaul BRUNAULT
Outcome results
None listed