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临床试验/NCT04236531
NCT04236531Unknown不适用

Source-monitoring Processes and Risk for Psychosis

Hôpital le Vinatier3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
3
主要终点
Source-monitoring performances

研究概览

简要总结

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Some studies have showed source-monitoring deficits in patients with schizophrenia as well as in individuals at ultra-high risk for psychosis (UHR) and in first-episode psychosis patients (FEP). Source-monitoring deficits have thus been proposed as a potential early risk factor for psychosis. However, further studies are needed to better characterize this deficit.

The aim of this project is to investigate source-monitoring performances in UHR, FEP patients and healthy controls (HC) and to characterize these deficits in terms of brain anatomy, basic auditory processes and social functioning.

详细描述

Ninety participants will be included in the study: 30 UHR, 30 FEP and 30 healthy controls. All the participants will complete a standardized source-monitoring task, an MRI acquisition (3D-T1 anatomical scan), a tone-matching task as well as a socio-demographic and clinical evaluation including an assessment of the social functioning.

研究设计

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and Women aged between 18 and 30
  • Having given their written informed consent
  • French speakers and readers
  • Absence of hearing impairments (or tinnitus) that could prevent the successful completion of tasks involving listening to sounds or words
  • Absence of visual impairments that could prevent the successful completion of tasks involving reading on the screen
  • For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM5), absence of psychotic prodromes measured by a score of less than 6 in the "prodromal questionnaire" - PQ-16 (Ising et al., 2012), absence of drug treatments (except oral contraception).
  • For the UHR group, meeting the UHR criteria according to the "Comprehensive Assessment of at-risk mental state" (CAARMS).
  • For the FEP group, presenting with daily psychotic symptoms for at least a week.

排除标准

  • Do not consent to be included in the study
  • Contraindication to MRI scan
  • History of neurological disease
  • Pregnancy
  • Being under tutorship or curatorship
  • Having developed musical abilities (that is, regularly practicing a musical instrument)

结局指标

主要结局

Source-monitoring performances

时间窗: one day

Scores obtained at a source-monitoring task (Brunelin et al., 2006)

次要结局

  • Brain gyrification(one day)
  • Working memory performances(one day)
  • Confidence in source-monitoring judgements(one day)
  • Grey matter volume(one day)
  • Basic auditory performances(one day)
  • Social functioning(one day)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (3)

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