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Not yet recruiting NCT07443800

Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia

No phase Interventional ADHD - Attention Deficit Disorder With Hyperactivity Fibromyalgia (FM) Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Samples, Questionnaires, Sensitivity to mechanical pain.
Who it may be relevant to
Registry conditions: ADHD - Attention Deficit Disorder With Hyperactivity, Fibromyalgia (FM), Chronic Pain. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comorbidity Between Attention Deficit Hyperactivity Disorder (ADHD) and Fibromyalgia: Cross-prevalence in Patients Treated for ADHD Who Are naïve to Methylphenidate, ADHD Treated With Methylphenidate, or Fibromyalgia, and Associated Metabolomic Factors

Overview

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

  • Biological Samples
    Blood and urine samples including metabolomic analyses.
  • Other Questionnaires
    Completing self-assessment questionnaires
  • Other Sensitivity to mechanical pain
    Assessment of sensitivity to mechanical pain (by using the Von Frey monofilament test)

Primary outcome measures

  • Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment [Time frame: Baseline]
Secondary outcome measures (10)
  • Percentage of patients with fibromyalgia among patients with ADHD and a current methylphenidate treatment [Time frame: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD [Time frame: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia [Time frame: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD [Time frame: Baseline]
  • 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, [Time frame: Baseline]
  • 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 [Time frame: Baseline]
  • 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 [Time frame: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD [Time frame: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia [Time frame: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD [Time frame: Baseline]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07443800 · DR250012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗