Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia

NCT07443800 | Not Yet Recruiting

• 1 other identifier: DR250012
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; Fibromyalgia (FM); Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (10)

• 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

Study Arms (1)

Patients with fibromyalgia being treated for ADHD

EXPERIMENTAL

Biological: Samples; Other: Questionnaires; Other: Sensitivity to mechanical pain

Interventions

Samples BIOLOGICAL

Blood and urine samples including metabolomic analyses.

Patients with fibromyalgia being treated for ADHD

Questionnaires OTHER

Completing self-assessment questionnaires

Patients with fibromyalgia being treated for ADHD

Sensitivity to mechanical pain OTHER

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

Patients with fibromyalgia being treated for ADHD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Fibromyalgia; Chronic Pain

Interventions

Sampling Studies; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Data Collection

Central Study Contacts

Paul BRUNAULT

CONTACT

02 18 37 05 81; paul.brunault@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06