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

Completed

• Conditions: Depressive Episode

• Registration Number: NCT05654948
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Study Start: 2023-02-09
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MADRS score	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.
Simple reaction time (SRT) obtained at the MindPulse test	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.
Go/NoGo score obtained at the MindPulse test	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).
Executive speed (ES) obtained at the MindPulse test	Baseline	The ES Score corresponds to the Executive Speed, i.e. the average time of categorisation of the subject.
Reaction to difficulty obtained at the MindPulse test	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 Outcome Measures

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

Trial Locations

Locations (1)

Clinique psychiatrique universitaire; 🇫🇷 Tours, France