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

Depressive Episode Clinical Trial

— MINDDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654948
• Other study ID #: DR220190-MINDDE
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Tours
• Contact: Wissam EL HAGE
• Phone: 0247476529
• Email: wissam.elhage[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Episode

Intervention

Other:
• computerised 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

Locations

Country	Name	City	State
France	Clinique psychiatrique universitaire	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Level of anxiety	measured by a self-questionnaire : State Trait Anxiety Inventory (STAI) 40 items rated from 1 to 4	Baseline
Secondary	clinical characterisation	Measured by a scale : Transdiagnostic Skills Scale (T2S) 42 items rated from 1 to 7	Baseline
Secondary	clinical characterisation	Measured by a questionnaire : Transdiagnostic Evaluation Scale (ETE) 66 items rated from 1 to 7	Baseline
Secondary	insomnia severity	Measured by an insomnia severity index (ISI) 5 items rated from 0 to 4	Baseline
Secondary	Stroop test	standardised cognitive assessment is measured by neuropsycological tests as stroop test	Baseline
Secondary	D2R	standardised cognitive assessment is measured by neuropsycological tests as D2R test that measures the concentration	Baseline
Secondary	Finger tapping test	standardised cognitive assessment is measured by neuropsycological tests as Finger tapping test rated from 0 to 4	Baseline