跳至主要内容
临床试验/NCT03481192
NCT03481192Unknown不适用

Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
103
试验地点
2
主要终点
Evaluation of the episodic score recall of the first interview (T1) at T2

研究概览

简要总结

To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project.

详细描述

The methodology will compare the episodic memory results of patients admitted for IMV who have exclusively ingested amnesic substances to a subject control group that has made IMV with non-amnesic substances such as paracetamol. The purpose of this comparison is to ensure that memory problems are not related to the context of the suicidal crisis.

The second step will be able to relate the memory score of the predictor variables. To achieve this, it will perform a multivariate linear regression in each group in order to confirm the results of the pilot study and to be able to regress in the control group which was not possible in the pilot study because of the lack of effective.

Finally, this study will try to establish, using Receiver Operating Characteristic (ROC) curves, thresholds for cognitive scores and begin to develop a tool for clinical practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Group amnesic substances :
  • Age from 18 to 65 years
  • Admitted to emergencies for IMV by benzodiazepines
  • Supported at Toulouse University Hospital (hospitalization, outpatient)
  • Group control :
  • Age from 18 to 65 years
  • Admitted to emergencies for IMV by non-depressive substances of the central nervous system
  • Supported at Toulouse University Hospital (hospitalization, outpatient)

排除标准

  • Cognitive Disorder Due to an Organic Disorder Neuro Degenerative Disease, Korsakoff Syndrome) or Mental Retardation Diagnosed
  • Patient under guardianship
  • Not speaking and / or not reading French
  • Neurodegenerative disease diagnosed

研究组 & 干预措施

A group using amnesic substances

Experimental

A group of patients admitted for IMV exclusively using amnesic substances. Benzodiazepines, benzodiazepines, tricyclic antidepressants, neuroleptics, antihistamines, other atropine substances, anti-epileptics and opiates.

Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place.

干预措施: Two visits for evaluation (Behavioral)

A control group

Active Comparator

A control group that ingested exclusively non-amnesic substances among them most frequently ingested in this context, ie the following classes: level 1 analgesics, antibiotics, serotonergic and noradrenergic antidepressants, oral antidiabetic, thyroid hormones, anti oral coagulant.

Two visits for evaluation, the first one for the first evaluation of cognitive functions directly following the psychiatric interview, and the second one at 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place.

干预措施: Two visits for evaluation (Behavioral)

结局指标

主要结局

Evaluation of the episodic score recall of the first interview (T1) at T2

时间窗: Just After/24-48h after the psychiatric interview

This score is based on the episodic scale. The episodic score is a reflection of the patient's memory of the emergency psychiatric assessment. In this study, this score will be used as a variable independent of the multivariate linear regression, the objective of the study being to identify the variables significantly related to this score. The total episodicity score is calculated by adding the episodic scores of several events. A continuous score is obtained and between 0 and 38.

次要结局

  • Specificity score of each test for the episodic memory test(Just After/24-48h after the psychiatric interview)
  • Comparison of cognitive scores between the amnesic substances group and the control group using the The Memory Functioning Questionnaire (MFQ) abridged version of tthe Memory Functioning Questionnaire(Just After/24-48h after the psychiatric interview)
  • Sensitivity score of each test for the episodic memory test(Just After/24-48h after the psychiatric interview)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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