Clinical trial NCT05654948: Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode
Official title: Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Episode
Keywords: depression
fundamental decision
computerised cognitive performance test
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people suffering from a characterised depressive episode

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.

Eligibility criteria: 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

Primary outcomes:
measure: MADRS score
timeFrame: baseline
measure: Simple reaction time (SRT) obtained at the MindPulse test
timeFrame: Baseline
measure: Go/NoGo score obtained at the MindPulse test
timeFrame: Baseline
measure: Executive speed (ES) obtained at the MindPulse test
timeFrame: Baseline
measure: Reaction to difficulty obtained at the MindPulse test
timeFrame: Baseline
Secondary outcomes:
measure: Level of anxiety
timeFrame: Baseline
measure: clinical characterisation
timeFrame: Baseline
measure: clinical characterisation
timeFrame: Baseline
measure: insomnia severity
timeFrame: Baseline
measure: Stroop test
timeFrame: Baseline
measure: D2R
timeFrame: Baseline
measure: Finger tapping test
timeFrame: Baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: Clinique psychiatrique universitaire
Study officials:
affiliation: CHU Tours
name: Wissam EL HAGE
role: PRINCIPAL_INVESTIGATOR
References: