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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Episode
• Intervention / Treatment: Other: computerised cognitive performance test : MindPulse

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Clinique psychiatrique universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

people suffering from a characterised depressive episode

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Wissam EL HAGE, CHU Tours

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: depression; fundamental decision; computerised cognitive performance test
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: DR220190-MINDDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No