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Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode

Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05654948
Acronym
MINDDE
Enrollment
80
Registered
2022-12-16
Start date
2023-02-09
Completion date
2024-04-25
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Episode

Keywords

depression, fundamental decision, computerised cognitive performance test

Brief summary

The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.

Detailed description

The investigators will include patients suffering from MDD, in episode. The patients will be evaluated with the MINI-7 interview. Then, the participants will undertake different neuropsychological tasks evaluating executive function: the stroop task, the D2 tasks, the finger tapping test and the mindpulse. The participants will also undertake clinical evaluation the MADRS, the Transdiagnostic Skills Scale, the Symptomatic Transdiagnostic Test, the STAI and the Severity Insomnia Indexes. The investigators will perform correlational analysis between the neuropsychological tasks and the clinical evaluations. The investigators will also compare the predictive power of the different neuropsychological tasks on depressive symptoms.

Interventions

OTHERcomputerised cognitive performance test : MindPulse

In practice, this tool measures the speed at which an individual reacts to the appearance of a simple image on a screen with instructions to react only to certain images. It thus makes it possible to measure the speed of information processing, attention, executive functions and reaction to difficulty

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age between 18 and 65 years. * Diagnosis of a depressive episode according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0 according to DSM-5). * No evidence of bipolar disorder or schizophrenia, confirmed by the MINI. * No dementing neurological disease. * No guardianship or trusteeship

Exclusion criteria

* Opposition to data processing * Depressive episode in the context of a known bipolar disorder or schizophrenic illness

Design outcomes

Primary

MeasureTime frameDescription
MADRS scorebaselineThe severity of the depression will be assessed using the MADRS score. Montgomery-Asberg Depression Scale (MADRS) The scale has 10 items rated from 0 to 6. 0 to 6 points: the patient is considered healthy. 7 to 19 points: the patient is considered to be in mild depression. 20 to 34 points: the patient is considered to be in moderate depression. \> 34 points: the patient is considered to be in severe depression.
Simple reaction time (SRT) obtained at the MindPulse testBaselineThe simple reaction time (SRT) is the reaction time to the first test (the subject releases the mouse click as quickly as possible when an image appears) , it contains the time needed to perceive and analyse the image, to formulate the response and to execute the motor response.
Go/NoGo score obtained at the MindPulse testBaselinereaction time with a categorisation where the subject must react or not react (Go/NoGo) according to the categorical target, in this case a light or dark colour (white coloured image or grey coloured image).
Executive speed (ES) obtained at the MindPulse testBaselineThe ES Score corresponds to the Executive Speed, i.e. the average time of categorisation of the subject.
Reaction to difficulty obtained at the MindPulse testBaselineIt corresponds to the adaptation of the subject to the level of difficulty. The shift of the circle above the blue rectangle indicates a higher than expected slowing down in reaction to the difficulty of the instruction, while a shift below the blue rectangle indicates that the participant is not slowing down enough in response to the difficulty and is at risk of making mistakes.

Secondary

MeasureTime frameDescription
Level of anxietyBaselinemeasured by a self-questionnaire : State Trait Anxiety Inventory (STAI) 40 items rated from 1 to 4
Finger tapping testBaselinestandardised cognitive assessment is measured by neuropsycological tests as Finger tapping test rated from 0 to 4
clinical characterisationBaselineMeasured by a scale : Transdiagnostic Skills Scale (T2S) 42 items rated from 1 to 7
insomnia severityBaselineMeasured by an insomnia severity index (ISI) 5 items rated from 0 to 4
Stroop testBaselinestandardised cognitive assessment is measured by neuropsycological tests as stroop test
D2RBaselinestandardised cognitive assessment is measured by neuropsycological tests as D2R test that measures the concentration

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026