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Emotional Dysregulation in Adult ADHD. (EMO-TDA)

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ClinicalTrials.gov Identifier: NCT03494478
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date March 12, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: Change in measure between inclusion and 12 months after inclusion ]
    Score of cyclothymia (TEMPS-A scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: Change in measure between inclusion and 12 months after inclusion ]
    Score of emotional lability (ALS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: Change in measure between inclusion and 12 months after inclusion ]
    Score of emotional dysregulation (WRAADDS scale)
  • Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: Change in measure between inclusion and 12 months after inclusion ]
    Score of borderline personality symptoms (BSL scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Association between emotional dysregulation, cognitive deficits and circadian instability [ Time Frame: Change en measure between inclusion and 12 months after inclusion ]
    Correlation between emotional dysregulation and executive and attentional dysfunction measured with the TAP test.
  • Association between emotional dysregulation, cognitive deficits and circadian instability [ Time Frame: Change en measure between inclusion and 12 months after inclusion ]
    Correlation between emotional dysregulation and instability index of circadian rhythms measured by actimetry.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotional Dysregulation in Adult ADHD.
Official Title  ICMJE Emotional Dysregulation and Cyclothymia in Adult Patients With ADHD: Cohort Follow-up of Patients in Two Referral Centers
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Adult ADHD
Intervention  ICMJE
  • 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 Name: 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.
Study Arms  ICMJE Experimental: Cohort group
All participants will have evaluations at inclusion and 12 months. Neuropsychological testing Actimetry Selfquestionnaires on emotional topics
Interventions:
  • Other: Neuropsychological testing
  • Other: Actimetry
  • Other: Self-questionnaires on emotional topics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Madoé JULIANS, CRA 03 88 11 61 86 ext +33 madoe.julians@chru-strasbourg.fr
Contact: Hélène SOAVELO, PC 03 88 11 65 59 ext +33 helene.soavelo@chru-strasbourg.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494478
Other Study ID Numbers  ICMJE 6795
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sébastien WEIBEL, MD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP