跳至主要内容
临床试验/NCT03494478
NCT03494478进行中(未招募)不适用

Emotional Dysregulation and Cyclothymia in Adult Patients With ADHD: Cohort Follow-up of Patients in Two Referral Centers

University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
4
主要终点
Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

研究概览

简要总结

Attention deficit disorder in adults with or without hyperactivity (ADHD) is a common disorder, affecting around 3% of the population. ADHD increases the risk of psychiatric disorders (mood disorders, sleep disorders, personality disorders, addictive behavior), risky behaviors, and vocational difficulties. Emotional dysregulation (ED) constitute a major hindrance in the daily life of subjects, with a great impact on the general functioning and the quality of life of the patients.

The investigators want to determine the characteristics of patients with each type of ED (impulsivity, exacerbated emotional intensity, cyclothymia, borderline personality traits), and study the stability of these traits over time. Since circadian rhythms influence mood and circadian rhythms frequently occur in patients with ADHD, the investigators want to determine if there is a link between ED and instability in circadian rhythms. Finally, they would like to observe whether the ED evolves and according to whether or not treatment is taken

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged ≥ 18 years
  • diagnosis of adult ADHD prior to inclusion
  • Affiliated to a social health insurance
  • Subject having dated and signed informed consent
  • Subject having been informed of the results of the prior medical examination

排除标准

  • Mobility project preventing follow-up for 1 year (planned move)
  • impossibility to give the subject information enlightened (subject in emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language ...)
  • Subject under the protection of justice
  • Subject under guardianship or curatorship
  • Pregnancy
  • Breastfeeding

结局指标

主要结局

Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

时间窗: At 12 months after inclusion

Score of cyclothymia (TEMPS-A scale)

次要结局

  • Association between emotional dysregulation, cognitive deficits and circadian instability(At 12 months after inclusion)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (4)

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