Clinical trial NCT03494478: Emotional Dysregulation in Adult ADHD.
Official title: Emotional Dysregulation and Cyclothymia in Adult Patients With ADHD: Cohort Follow-up of Patients in Two Referral Centers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult ADHD
Keywords: Cohort study
Emotion dysregulation
Questionnaires
Actimetry
Neuropsychology
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At 12 months after inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At 12 months after inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At 12 months after inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At inclusion
measure: Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)
timeFrame: At 12 months after inclusion
Secondary outcomes:
measure: Association between emotional dysregulation, cognitive deficits and circadian instability
timeFrame: At inclusion
measure: Association between emotional dysregulation, cognitive deficits and circadian instability
timeFrame: At 12 months after inclusion
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Centre Hospitalier Spécialisé de Rouffach - Secteur 8
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Sébastien WEIBEL, MD
role: PRINCIPAL_INVESTIGATOR
References: