NCT03494478

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3.6 years

First QC Date

March 23, 2018

Last Update Submit

April 14, 2023

Conditions

Adult ADHD

Keywords

Cohort studyEmotion dysregulationQuestionnairesActimetryNeuropsychology

Outcome Measures

Primary Outcomes (8)

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

    Score of cyclothymia (TEMPS-A scale)

    At inclusion

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

    Score of cyclothymia (TEMPS-A scale)

    At 12 months after inclusion

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

    Score of emotional lability (ALS scale)

    At inclusion

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

    Score of emotional lability (ALS scale)

    At 12 months after inclusion

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

    Score of emotional dysregulation (WRAADDS scale)

    At inclusion

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

    Score of emotional dysregulation (WRAADDS scale)

    At 12 months after inclusion

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

    Score of borderline personality symptoms (BSL scale)

    At inclusion

  • 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 Outcomes (2)

  • Association between emotional dysregulation, cognitive deficits and circadian instability

    At inclusion

  • Association between emotional dysregulation, cognitive deficits and circadian instability

    At 12 months after inclusion

Study Arms (1)

Cohort group

EXPERIMENTAL

All participants will have evaluations at inclusion and 12 months. Neuropsychological testing Actimetry Selfquestionnaires on emotional topics

Other: Neuropsychological testingOther: ActimetryOther: Self-questionnaires on emotional topics

Interventions

Neuropsychological testingOTHER

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

Also known as: attention, working memory, executive functions
Cohort group
ActimetryOTHER

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

Also known as: Selfquestionnaires on emotional topics
Cohort group
Self-questionnaires on emotional topicsOTHER

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

Cohort group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged ≥ 18 years
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Spécialisé de Rouffach - Secteur 8

Rouffach, 68250, France

Location

Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Sébastien WEIBEL, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 11, 2018

Study Start

October 30, 2019

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)