Emotional Dysregulation in Adult ADHD. (EMO-TDA)

April 14, 2023 updated by: University Hospital, Strasbourg, France

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Rouffach, France, 68250
        • Centre Hospitalier Spécialisé de Rouffach - Secteur 8
        • Contact:
        • Contact:
      • Strasbourg, France, 67091
        • Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM
        • Contact:
        • Sub-Investigator:
          • Charlotte KRAEMER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort group
All participants will have evaluations at inclusion and 12 months. Neuropsychological testing Actimetry Selfquestionnaires on emotional topics
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 Names:
  • attention
  • working memory
  • executive functions
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 Names:
  • Selfquestionnaires on emotional topics
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At inclusion
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.
At 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Sébastien WEIBEL, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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