NCT07443800尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Percentage of patients with fibromyalgia among patients with ADHD and no prior methylphenidate treatment
时间窗: 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
次要结局
- 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)
- 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(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(Baseline)
- Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia without ADHD(Baseline)
- Comparison of the levels of 500 biomarkers of neurotransmission between patients with: ADHD without fibromyalgia(Baseline)
- Comparison of the levels of 500 biomarkers of neurotransmission between patients with fibromyalgia with ADHD(Baseline)
研究者
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