Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emotional Dysregulation in Adult ADHD. (EMO-TDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease Intervention/treatment Phase
Adult ADHD Other: Neuropsychological testing Other: Actimetry Other: Self-questionnaires on emotional topics Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Emotional Dysregulation and Cyclothymia in Adult Patients With ADHD: Cohort Follow-up of Patients in Two Referral Centers
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: At inclusion ]
    Score of cyclothymia (TEMPS-A scale)

  2. 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)

  3. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: At inclusion ]
    Score of emotional lability (ALS scale)

  4. 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)

  5. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: At inclusion ]
    Score of emotional dysregulation (WRAADDS scale)

  6. 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)

  7. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) [ Time Frame: At inclusion ]
    Score of borderline personality symptoms (BSL scale)

  8. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494478


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
France
Centre Hospitalier Spécialisé de Rouffach - Secteur 8
Rouffach, France, 68250
Contact: Fabrice DUVAL, MD    03 89 78 70 18 ext +33    f.duval@ch-rouffach.fr   
Contact: Alexis ERB, MD    03 89 78 70 18 ext +33    a.erb@ch-rouffach.fr   
Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM
Strasbourg, France, 67091
Contact: Sébastien WEIBEL, MD    03 88 11 51 57 ext +33    sebastien.weibel@chru-strasbourg.fr   
Contact: Gilles BERTSCHY, MD    03 88 11 65 48 ext +33    gilles.bertschy@chru-strasbourg.fr   
Sub-Investigator: Charlotte KRAEMER, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Layout table for investigator information
Principal Investigator: Sébastien WEIBEL, MD Hôpitaux Universitaires de Strasbourg
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03494478    
Other Study ID Numbers: 6795
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Cohort study
Emotion dysregulation
Questionnaires
Actimetry
Neuropsychology