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Adult ADHDEMO-TDANCT03494478

Emotional Dysregulation in Adult ADHD.

A study testing Neuropsychological testing, Actimetry and Self-questionnaires on emotional topics in people with Adult ADHD, run by University Hospital, Strasbourg, France at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult ADHD
What is being tested?
Neuropsychological testing, Actimetry and Self-questionnaires on emotional topics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesFrance
Study dates
30 Oct 2019to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier Spécialisé de Rouffach - Secteur 8

    Rouffach, 68250

  • Hôpitaux Universitaires de Strasbourg - Service de Psyhciatrie 2/PPSAM

    Strasbourg, 67091

Other trials in France

About this study

Official title: 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

Conditions
Adult ADHD
Being tested
Neuropsychological testing, Actimetry, Self-questionnaires on emotional topics
Keywords
Cohort study, Emotion dysregulation, Questionnaires, Actimetry, Neuropsychology
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuropsychological testingOther

    Also called attention, working memory, executive functions

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

  • ActimetryOther

    Also called Selfquestionnaires 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.

  • 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.

Study groups in NCT03494478
Study groupRoleWhat they receive
Cohort groupExperimentalAll participants will have evaluations at inclusion and 12 months. Neuropsychological testing Actimetry Selfquestionnaires on emotional topics
Receives: Other: Neuropsychological testing; Other: Actimetry; Other: Self-questionnaires on emotional topics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of cyclothymia (TEMPS-A scale)

    Measured: At inclusion

  2. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of cyclothymia (TEMPS-A scale)

    Measured: At 12 months after inclusion

  3. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of emotional lability (ALS scale)

    Measured: At inclusion

  4. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of emotional lability (ALS scale)

    Measured: At 12 months after inclusion

  5. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of emotional dysregulation (WRAADDS scale)

    Measured: At inclusion

  6. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of emotional dysregulation (WRAADDS scale)

    Measured: At 12 months after inclusion

  7. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of borderline personality symptoms (BSL scale)

    Measured: At inclusion

  8. Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation)

    Score of borderline personality symptoms (BSL scale)

    Measured: At 12 months after inclusion

Secondary outcomes (2)

  1. 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.

    Measured: At inclusion

  2. 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.

    Measured: At 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start30 Oct 2019
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03494478
Sponsor's protocol ID
6795
Acronym
EMO-TDA
Status last verified
Apr 2023
First submitted
23 Mar 2018
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walter A, Martz E, Weiner L, Comtet H, Glacet R, Kilic-Huck U, Bourgin P, Schroder CM, Weibel S. Sleep, rest-activity rhythm, cognitive and emotional symptoms in adult ADHD: unraveling the links with an actimetry-based approach. BMC Psychiatry. 2026 Mar 9;26(1):317. doi: 10.1186/s12888-026-07947-9.

    PubMed 41803808

Questions about this trial

What is this clinical trial studying?

A study testing Neuropsychological testing, Actimetry and Self-questionnaires on emotional topics in people with Adult ADHD, run by University Hospital, Strasbourg, France at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterization of emotional dysregulation (descriptive analysis of different scales assessing emotional dysregulation) (time frame: At inclusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03494478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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