Clinical trial NCT03296384: Influence of Environmental Factors and Schizophrenia
Official title: Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Schizophrenia
Relatives
Keywords: schizophrenia
environmental factors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut national d'étude démographique (INED)
name: CPN (INSERM U894) CH Sainte-Anne - Paris
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Fondation FondaMental
name: University Hospital, Clermont-Ferrand
First posted: 2017-09-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

All subjects

* Age \> 18 years
* Somatic state / condition and level of understanding (language, intellectual level) compatible with the data collection (interview, self-administered questionnaires)

Patients

* 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

Relatives

* Protective Measures (tutor, curator)

Exclusion criteria:

Patients

* The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data

Primary outcomes:
measure: 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)
timeFrame: 56 months, From March 2014 to November 2018
measure: The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE
timeFrame: 56 months, From March 2014 to November 2018
Secondary outcomes:
measure: The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments
timeFrame: 56 months, From March 2014 to November 2018
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Franck Schürhoff, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Clermont-Ferrand
name: Pierre-Michel Llorca, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: