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临床试验/NCT02834208
NCT02834208Unknown不适用

Neurofunctional Basis of Emotion Processing: Clinical, Genetic, Biological and Imaging Study in Patients With Schizophrenia and Healthy Relatives of Patients in Comparison With a Control Group

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年12月1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
105
试验地点
1
主要终点
Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI

研究概览

简要总结

Schizophrenia is an invalidating psychiatric illness with a strong genetic component characterized by abnormal processing of emotional information. This alteration in emotion processing has been described in acute as well as in remission phases of the illness. It has also been found in healthy relatives of patients with schizophrenia and in subjects at high risk of psychosis. Thus, alterations in emotional information processing are not only linked to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In addition, schizophrenia patients differ from healthy controls in neural activity in brain regions implicated in emotions processing. However, interpretation of findings in patients is limited by confounding factors, such as antipsychotic treatments or alterations due to the course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene expression) underlying these patterns of cerebral activation in emotion information processing.

So, the main objective of this study is to compare the cerebral activity of schizophrenia patients to that of healthy siblings and healthy controls in an emotional processing task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female participant, right-handed, aged from 18 to 45 years old
  • •Haven given their written consent
  • •DSM-5 (Diagnostic and Statistical Manual of Mental Disorders version 5) diagnosis of schizophrenia
  • •Remitted phase (criteria of Andreasen)
  • •Stable doses of antipsychotics during the last 6 weeks
  • •No severe somatic illness
  • •Normal clinical exam
  • •Inscription to the social security

排除标准

  • •Women in genitally active period without contraception
  • •Women pregnant or breast feeding
  • •Participants presenting a severe somatic /neurologic condition
  • •Present/history in the last year of alcohol or drug abuse
  • •Participating in another clinical study or still in period of exclusion of a previous clinical trial
  • •Contraindication to an MRI test (metallic foreign body, pacemaker, heart valve, chirurgical clip, claustrophobia...)

研究组 & 干预措施

Schizophrenia subjects

Experimental

35 patients suffering from schizophrenia

干预措施: Polymorphism (SNP in DNA) (Genetic)

Healthy siblings

Other

35 healthy siblings of the patients suffering from schizophrenia

干预措施: MRI (Magnetic resonance imaging) (Other)

Schizophrenia subjects

Experimental

35 patients suffering from schizophrenia

干预措施: quantitative measures of mRNA (Genetic)

Schizophrenia subjects

Experimental

35 patients suffering from schizophrenia

干预措施: Neuropsychological assessment (Other)

Schizophrenia subjects

Experimental

35 patients suffering from schizophrenia

干预措施: MRI (Magnetic resonance imaging) (Other)

Healthy siblings

Other

35 healthy siblings of the patients suffering from schizophrenia

干预措施: Polymorphism (SNP in DNA) (Genetic)

Healthy siblings

Other

35 healthy siblings of the patients suffering from schizophrenia

干预措施: quantitative measures of mRNA (Genetic)

Healthy siblings

Other

35 healthy siblings of the patients suffering from schizophrenia

干预措施: Neuropsychological assessment (Other)

Healthy controls

Other

35 healthy "controls "patients

干预措施: MRI (Magnetic resonance imaging) (Other)

Healthy controls

Other

35 healthy "controls "patients

干预措施: Polymorphism (SNP in DNA) (Genetic)

Healthy controls

Other

35 healthy "controls "patients

干预措施: quantitative measures of mRNA (Genetic)

Healthy controls

Other

35 healthy "controls "patients

干预措施: Neuropsychological assessment (Other)

结局指标

主要结局

Blood Oxygen Level dependent (BOLD) signal activity in Anterior Cingulate Cortex (ACC) measured by functional MRI

时间窗: 4 hours

次要结局

  • Assessment of the functional connectivity in cortico-limbic circuit which underlie the emotional information using functional MRI(4 hours)
  • Description of whole brain neuro-anatomy based using Voxel Brain Morphometry (VBM)(4 hours)
  • Polymorphism (single-nucleotide polymorphism SNP) of DNA (DeoxyriboNucleic Acid)(4 hours)
  • Quantitative expression of messenger Ribo Nucleic Acid (mRNA) in Peripheral Blood Mononuclear Cells (PBMC)(4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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