Emotional Dysregulation in Adult ADHD.

Adult ADHD Clinical Trial

— EMO-TDA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03494478
• Other study ID #: 6795
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult ADHD

Intervention

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
• Actimetry
The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Spécialisé de Rouffach - Secteur 8	Rouffach
France	Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of cyclothymia (TEMPS-A scale)	At inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of cyclothymia (TEMPS-A scale)	At 12 months after inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of emotional lability (ALS scale)	At inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of emotional lability (ALS scale)	At 12 months after inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of emotional dysregulation (WRAADDS scale)	At inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of emotional dysregulation (WRAADDS scale)	At 12 months after inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of borderline personality symptoms (BSL scale)	At inclusion
Primary	Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)	Score of borderline personality symptoms (BSL scale)	At 12 months after inclusion
Secondary	Association between emotional dysregulation, cognitive deficits and circadian instability	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.	At inclusion
Secondary	Association between emotional dysregulation, cognitive deficits and circadian instability	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.	At 12 months after inclusion