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Набор скоро начнётся NCT07443800

Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia

Без фазы С лечением ADHD - Attention Deficit Disorder With Hyperactivity Fibromyalgia (FM) Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Samples, Questionnaires, Sensitivity to mechanical pain.
Кому может быть актуально
Состояния в реестре: ADHD - Attention Deficit Disorder With Hyperactivity, Fibromyalgia (FM), Chronic Pain. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Биопрепарат Samples
    Blood and urine samples including metabolomic analyses.
  • Другое Questionnaires
    Completing self-assessment questionnaires
  • Другое Sensitivity to mechanical pain
    Assessment of sensitivity to mechanical pain (by using the Von Frey monofilament test)

Первичные конечные точки

  • Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment [Срок оценки: Baseline]
Вторичные конечные точки (10)
  • Percentage of patients with fibromyalgia among patients with ADHD and a current methylphenidate treatment [Срок оценки: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia without ADHD [Срок оценки: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with ADHD without fibromyalgia [Срок оценки: Baseline]
  • Comparison of the levels of cytokines (specific biomarkers of inflammation), between patients with fibromyalgia with ADHD [Срок оценки: 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, [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD [Срок оценки: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia [Срок оценки: Baseline]
  • Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07443800 · DR250012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗