Emotional Dysregulation in Adult ADHD.

Overview

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

Full Title of Study: “Emotional Dysregulation and Cyclothymia in Adult Patients With ADHD: Cohort Follow-up of Patients in Two Referral Centers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

  • Other: Neuropsychological testing
    • The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up
  • Other: Actimetry
    • The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up.
  • Other: Self-questionnaires on emotional topics
    • The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up.

Arms, Groups and Cohorts

  • Experimental: Cohort group
    • All participants will have evaluations at inclusion and 12 months. Neuropsychological testing Actimetry Selfquestionnaires on emotional topics

Clinical Trial Outcome Measures

Primary Measures

  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At inclusion
    • Score of cyclothymia (TEMPS-A scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At 12 months after inclusion
    • Score of cyclothymia (TEMPS-A scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At inclusion
    • Score of emotional lability (ALS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At 12 months after inclusion
    • Score of emotional lability (ALS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At inclusion
    • Score of emotional dysregulation (WRAADDS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At 12 months after inclusion
    • Score of emotional dysregulation (WRAADDS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At inclusion
    • Score of borderline personality symptoms (BSL scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
    • Time Frame: At 12 months after inclusion
    • Score of borderline personality symptoms (BSL scale)

Secondary Measures

  • Association between emotional dysregulation, cognitive deficits and circadian instability
    • Time Frame: At inclusion
    • Correlation between emotional dysregulation and executive and attentional dysfunction measured with the TAP test. Correlation between emotional dysregulation and instability index of circadian rhythms measured by actimetry.
  • Association between emotional dysregulation, cognitive deficits and circadian instability
    • Time Frame: At 12 months after inclusion
    • Correlation between emotional dysregulation and executive and attentional dysfunction measured with the TAP test. Correlation between emotional dysregulation and instability index of circadian rhythms measured by actimetry.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sébastien WEIBEL, MD, Principal Investigator, Hôpitaux Universitaires de Strasbourg

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