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临床试验/NCT03649581
NCT03649581招募中不适用

Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
2
主要终点
Index of affect

研究概览

简要总结

The current diagnostic criteria for schizophrenia and other psychotic disorders are relatively broad and lack precision. Therefore, distinct diseases may be grouped together under the same diagnostic category, although these diseases may differ according to their clinical expression, prognosis and perhaps their physiopathological causes.

We think that identifying subforms of psychotic disorders that are more homogeneous will better enable to understand their respective physiopathological causes and find personalized treatments.

This study will compare two subforms of psychotic disorders that have been clinically distinguished in the 1970s. These phenotypes have however not been validated yet using scientific investigations.

Using clinical assessments, cognitive evaluations and neurophysiological measures (fMRI) investigating the domains of affect and psychomotoricity , we expect that these two subforms will differ on their clinical, cognitive and neurophysiological characteristics, namely: hebephrenia will be associated with deficits on the affect markers , and respect psychomotoricity (catatonia scales, tests assessing movement planification) whereas the opposite pattern will be observed for periodic catatonia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

  • for both patients and controls
  • male or female willing to participate and who have signed up the legal document
  • under the protection of health insurance for patients only
  • schizophrenia or schizo-affective disorder according to the DSM-5 criteria
  • periodic catatonia or hebephrenia accordin to WKL classification
  • clinically stable for at least 2 months
  • in or out patients for controls only
  • no psychiatric history

排除标准

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (epilepsia, brain injury, brain surgery…)
  • current substance use disorder (DSM-5)
  • current major depressive disorder (DSM-5)
  • mental retardation (IQ < 70)
  • pregnancy, breast feeding
  • current legal control
  • contra-indication for fMRI for controls only psychotropic intake during the last 3 weeks

结局指标

主要结局

Index of affect

时间窗: 6 months after inclusion

Compare two groups of markers relating respectively to affectivity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation

Index of psychomotoricity

时间窗: 6 months after inclusion

Compare two groups of markers relating to psychomotricity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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