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

NCT05654948 | Completed

• 1 other identifier: DR220190-MINDDE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Episode

Keywords

depression; fundamental decision; computerised cognitive performance test

Outcome Measures

Primary Outcomes (5)

• MADRS score

  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.

  baseline

• Simple reaction time (SRT) obtained at the MindPulse test

  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.

  Baseline

• Go/NoGo score obtained at the MindPulse test

  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).

  Baseline

• Executive speed (ES) obtained at the MindPulse test

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

  Baseline

• Reaction to difficulty obtained at the MindPulse test

  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.

  Baseline

Secondary Outcomes (7)

• Level of anxiety

  Baseline

• clinical characterisation

  Baseline

• clinical characterisation

  Baseline

• insomnia severity

  Baseline

• Stroop test

  Baseline

Interventions

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

Also known as: MindPulse

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

people suffering from a characterised depressive episode

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Clinique psychiatrique universitaire

Tours, 37044, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Wissam EL HAGE

  CHU Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 16, 2022
• Study Start: February 9, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

FR (1)