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临床试验/NCT03996122
NCT03996122Unknown不适用

Research of Anatomo-functional Biomarkers in Schizophrenia

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
functional resonance imaging: resting-state

研究概览

简要总结

To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

详细描述

The identification of biomarkers of ultra-resistance (UR) to treatment in schizophrenia would allow earlier, better adapted and more effective personalized management of these patients, which would improve their functional prognosis.

An early decrease in functional connectivity (FC) between some rest networks has recently been proposed as an UR biomarker by McNabb et al. Nevertheless, clozapine has, among its side effects, a direct cardiac action that profoundly modifies patient's hemodynamics. However, functional brain imaging techniques are based on BOLD effect which is dependent on these hemodynamic parameters. It is therefore not possible to say whether these differences in FC are inherent to the pathology or whether they are related to clozapine instauration which causes hemodynamic changes that may disturb BOLD signal.

To objectify UR biomarkers, investigators propose a longitudinal follow-up of resistant patients, starting before clozapine instauration and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, investigators will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • schizophrenia or schizoaffective disorder (DSM 5)
  • drug resistance
  • written patient approval
  • social security number in France
  • curator or tutor approval if needed

排除标准

  • pregnancy
  • other research participation
  • neurological evolution disorder
  • no MRI contraindication

结局指标

主要结局

functional resonance imaging: resting-state

时间窗: baseline, Month 2 and Month 6

Functional connectivity comparison between baseline, month 2 and month 6

次要结局

  • BDNF samples(baseline, Month 2 and Month 6)
  • functional resonance imaging: ASL(baseline, Month 2 and Month 6)
  • anatomical resonance imaging: T1(baseline, Month 2 and Month 6)
  • anatomical resonance imaging: DTI(baseline, Month 2 and Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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