Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07443800

Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chronic Pain Fibromyalgia Fibromyalgia (FM) Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

samples

Biological

Blood and urine samples including metabolomic analyses.

questionnaires

Other

Completing self-assessment questionnaires

Sensitivity to mechanical pain

Other

Assessment of sensitivity to mechanical pain (by using the Von Frey monofilament test)

Primary outcomes

  1. 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

  1. Percentage of patients with fibromyalgia among patients with ADHD and a current 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 a current methylphenidate treatment versus the theoretical prevalence of fibromyalgia in the French overall population

  2. Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD

    Time frame: 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)

  3. Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia

    Time frame: 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)

  4. Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD

    Time frame: 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)

  5. 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

    Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses

  6. 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

    Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses

  7. 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

    Plasma and urine levels of tryptophane derivatives short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses

  8. Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD

    Time frame: 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)

  9. Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia

    Time frame: 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)

  10. Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Paul BRUNAULT

CONTACT

[email protected]

02 18 37 05 81

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: HYPERPAIN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.