ADHD - Attention Deficit Disorder With HyperactivityHYPERPAINNCT07443800
Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia
A study testing Samples, Questionnaires and Sensitivity to mechanical pain in people with ADHD - Attention Deficit Disorder With Hyperactivity and Fibromyalgia (FM), run by University Hospital, Tours.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity, Fibromyalgia (FM), Chronic Pain
- What is being tested?
- Samples, Questionnaires and Sensitivity to mechanical pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Samples, Questionnaires, Sensitivity to mechanical pain
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesBiological
Blood and urine samples including metabolomic analyses.
QuestionnairesOther
Completing self-assessment questionnaires
Sensitivity to mechanical painOther
Assessment of sensitivity to mechanical pain (by using the Von Frey monofilament test)
| Study group | Role | What they receive |
|---|---|---|
| Patients with fibromyalgia being treated for ADHD | Experimental | Not described Receives: Biological: Samples; Other: Questionnaires; Other: Sensitivity to mechanical pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment
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
Measured: Baseline
Secondary outcomes (10)
Percentage of patients with fibromyalgia among patients with ADHD and a current methylphenidate treatment
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
Measured: Baseline
Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD
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)
Measured: Baseline
Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia
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)
Measured: Baseline
Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD
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)
Measured: 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,
Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
Measured: 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
Plasma and urine levels of tryptophane derivatives, short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
Measured: 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
Plasma and urine levels of tryptophane derivatives short carbon chain fatty acids and lipidomic profile, as assessed by metabolomic analyses
Measured: Baseline
Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD
Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography)
Measured: Baseline
Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia
Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography)
Measured: Baseline
Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD
Plasma and urine levels of 500 different biomarkers of neurotransmission (e.g., dopaminergic, serotoninergic, noradrenegic), as assessed by metabolomic analyses (high-performance liquid chromatography)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443800
- Sponsor's protocol ID
- DR250012
- Acronym
- HYPERPAIN
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07443800
- Acronym / sponsor ID
- HYPERPAIN / DR250012
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fibromyalgia being treated for ADHD | Experimental | Biological: Samples, Other: Questionnaires, Other: Sensitivity to mechanical pain |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplesBlood and urine samples including metabolomic analyses. | Biological | Patients with fibromyalgia being treated for ADHD |
| QuestionnairesCompleting self-assessment questionnaires | Other | Patients with fibromyalgia being treated for ADHD |
| Sensitivity to mechanical painAssessment of sensitivity to mechanical pain (by using the Von Frey monofilament test) | Other | Patients with fibromyalgia being treated for ADHD |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Samples, Questionnaires and Sensitivity to mechanical pain in people with ADHD - Attention Deficit Disorder With Hyperactivity and Fibromyalgia (FM), run by University Hospital, Tours.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul BRUNAULT (02 18 37 05 81, paul.brunault@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.