Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia (HYPERPAIN)

June 2, 2026 updated by: University Hospital, Tours

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with fibromyalgia being treated for ADHD
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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)
Baseline
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)
Baseline
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)
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
Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
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
Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
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
Plasma and urine levels of tryptophane derivatives short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
Baseline
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)
Baseline
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)
Baseline
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)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR250012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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