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临床试验/NCT06232226
NCT06232226招募中不适用

Addictions and Attention Deficit Disorder With or Without Hyperactivity

Nantes University Hospital4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
4
主要终点
Functional impairment

研究概览

简要总结

The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.

详细描述

Information on the study and diagnosis of ADHD will be carried out during a medical evaluation consultation, as part of routine care.

The two research visits (inclusion and at 12 months) will be added by the research and will each include:

  • A structured clinical interview with a research professional (traceability of oral consent, administration of structured interviews, collection of self-questionnaires, collection of care from the medical record)
  • A neuropsychological assessment with a neuropsychologist

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged over 18 years
  • For whom a diagnosis of ADHD has been confirmed less than 12 weeks ago
  • For whom the diagnosis of one or more addictive disorder(s) (substance use disorder or behavioral addiction) has been confirmed
  • Meeting the indication for treatment with MPH according to European recommendations (Kooij et al., 2019)
  • For patients who can actually benefit from MPH: who have not yet started taking MPH
  • Social security affiliates

排除标准

  • Presenting disorders of higher cognitive functions (at the discretion of the referring clinician or the investigator making the inclusion), making data collection impossible
  • Presenting difficulties in reading or writing the French language making data collection impossible
  • Unable to commit to being available for the 2 visits planned as part of the cohort
  • Under guardianship or legal protection
  • Patients who have used psychoactive substances within 12 hours prior to their visit

研究组 & 干预措施

Neuropsychological assessment

Other

Determination of the neuropsychological profile

干预措施: Patients suffering from the co-occurrence of ADHD and addiction(s) (Other)

结局指标

主要结局

Functional impairment

时间窗: Inclusion and 12-month follow-up

Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)

次要结局

  • Type and severity of ADHD(Inclusion)
  • Symptoms of ADHD(Inclusion and 12-month follow-up)
  • Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)(Inclusion and 12-month follow-up)
  • Addictive disorders - gambling disorder(Inclusion and 12-month follow-up)
  • Addictive disorders - sex addiction(Inclusion and 12-month follow-up)
  • Addictive disorders - eating addiction(Inclusion and 12-month follow-up)
  • Psychiatric disorders(Inclusion and 12-month follow-up)
  • Neuropsychological profile - selective attention(Inclusion and 12-month follow-up)
  • Neuropsychological profile - short-term and working memory(Inclusion and 12-month follow-up)
  • Neuropsychological profile - inhibition(Inclusion and 12-month follow-up)
  • Neuropsychological profile - spontaneous flexibility(Inclusion and 12-month follow-up)
  • Neuropsychological profile - planning(Inclusion and 12-month follow-up)
  • Psychopathological profile - impulsivity(Inclusion and 12-month follow-up)
  • Psychopathological profile - emotional dysregulation(Inclusion and 12-month follow-up)
  • Psychopathological profile - sensorial profile(Inclusion and 12-month follow-up)
  • Psychopathological profile - self-esteem(Inclusion and 12-month follow-up)
  • Quality of life survey(Inclusion and 12-month follow-up)
  • Care received(12-month follow-up)
  • Personal and family medical history(Inclusion)
  • Sociodemographics(Inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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