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临床试验/NCT03296384
NCT03296384Unknown不适用

Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
The prevalence of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV)) will be estimated from the census population-unit (unit TRIRIS INSEE)

研究概览

简要总结

Schizophrenia is a chronic and severe mental disorder with a lifetime prevalence of about 1 per cent, the symptoms can be very disabling and causing a heavy medical and socioeconomic.

There are significant variations from one population to another. Clinical manifestations of schizophrenia (symptoms, evolution, severity of disability) are highly variable. This variability, both epidemiological and clinical, is due to genetic and environmental factors.

Environmental factors may be either risk factors or modifying factors (changing clinical presentation but do not alter the risk of disease) for schizophrenia.

Environmental risk factors have been identified (eg: urbanity, cannabis, migration), but the investigators don't know neither the components directly responsible, nor the mechanisms by which they increase the risk of schizophrenia.

To date, there is no study has systematically evaluated the role of environmental modifying factors in schizophrenia.

Environmental factors may be individual, unique to each person (eg cannabis, migration.), or population-based (eg ethnic density, socio-economic difficulties.) The identification/ identifying of environmental risk factors or modifiers, both individual and population, may have theoretical implications (understanding of etiopathogenic mechanisms) and practical (implementation of preventive measures). The potential effectiveness of preventive measures is even greater than the risk attributable to certain environmental factors is important.

Most studies on environmental factors in schizophrenia were conducted in Anglo-Saxon countries and northern Europe, but no study of these risk factors has been conducted in France.

There are important differences environment based on study populations, these results are not generalizable to other countries, including France.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects
  • Age > 18 years
  • Somatic state / condition and level of understanding (language, intellectual level) compatible with the data collection (interview, self-administered questionnaires)
  • Diagnosis of schizophrenia according to DSM-IV criteria
  • Living in catchment areas
  • Non-Inclusion Criteria:
  • All subjects
  • Not affiliated to the social security scheme
  • inability to provide informed consent
  • Decompensated schizophrenic underway
  • Protective Measures (tutor, curator)
  • Exclusion criteria:
  • The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data

排除标准

  • 未提供

研究组 & 干预措施

Patients with schizophrenia

Other

干预措施: Clinical and environmental evaluation (Other)

Relatives

Other

干预措施: Clinical and environmental evaluation (Other)

结局指标

主要结局

The prevalence of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV)) will be estimated from the census population-unit (unit TRIRIS INSEE)

时间窗: 56 months, From March 2014 to November 2018

The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE

时间窗: 56 months, From March 2014 to November 2018

次要结局

  • The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments(56 months, From March 2014 to November 2018)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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