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Completed

NCT Number: NCT05654948

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

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.

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Key information

Conditions

Depressive Episode Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique psychiatrique universitaire

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computerised cognitive performance test : MindPulse

Other

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

Other names: MindPulse

Primary outcomes

  1. MADRS score

    Time frame: baseline

    The 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.

  2. Simple reaction time (SRT) obtained at the MindPulse test

    Time frame: Baseline

    The "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.

  3. Go/NoGo score obtained at the MindPulse test

    Time frame: Baseline

    reaction 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).

  4. Executive speed (ES) obtained at the MindPulse test

    Time frame: Baseline

    The ES Score corresponds to the Executive Speed, i.e. the average time of categorisation of the subject.

  5. Reaction to difficulty obtained at the MindPulse test

    Time frame: Baseline

    It 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 outcomes

  1. Level of anxiety

    Time frame: Baseline

    measured by a self-questionnaire : State Trait Anxiety Inventory (STAI) 40 items rated from 1 to 4

  2. clinical characterisation

    Time frame: Baseline

    Measured by a scale : Transdiagnostic Skills Scale (T2S) 42 items rated from 1 to 7

  3. clinical characterisation

    Time frame: Baseline

    Measured by a questionnaire : Transdiagnostic Evaluation Scale (ETE) 66 items rated from 1 to 7

  4. insomnia severity

    Time frame: Baseline

    Measured by an insomnia severity index (ISI) 5 items rated from 0 to 4

  5. Stroop test

    Time frame: Baseline

    standardised cognitive assessment is measured by neuropsycological tests as stroop test

  6. D2R

    Time frame: Baseline

    standardised cognitive assessment is measured by neuropsycological tests as D2R test that measures the concentration

  7. Finger tapping test

    Time frame: Baseline

    standardised cognitive assessment is measured by neuropsycological tests as Finger tapping test rated from 0 to 4

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MINDDE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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