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Clinical Trials/NCT07443800
NCT07443800
Not yet recruiting
Not Applicable

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

University Hospital, Tours0 sites100 target enrollmentStarted: April 1, 2026Last updated:
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InterventionsSamples, questionnaires, assessment of pain and sensitivity to pain

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts 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

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).

Arms & Interventions

Patients with fibromyalgia being treated for ADHD

Experimental

Intervention: Samples, questionnaires, assessment of pain and sensitivity to pain (Other)

Outcomes

Primary Outcomes

Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment

Time Frame: 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 Outcomes

  • Percentage of patients with fibromyalgia among patients with ADHD and a current methylphenidate treatment(Baseline)
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD(Baseline)
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia(Baseline)
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD(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,(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(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(Baseline)
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD(Baseline)
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia(Baseline)
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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