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临床试验/NCT05654948
NCT05654948已完成不适用

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

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
MADRS score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

MADRS score

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Level of anxiety(Baseline)
  • clinical characterisation(Baseline)
  • Finger tapping test(Baseline)
  • insomnia severity(Baseline)
  • Stroop test(Baseline)
  • D2R(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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