Influence of Environmental Factors and Schizophrenia

Not Applicable

• Conditions: Patients With Schizophrenia; Relatives
• Interventions: Other: Clinical and environmental evaluation

• Registration Number: NCT03296384
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-09-01
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-27
• Last Update Submitted: 2017-09-27
• Study First Posted: 2017-09-28
• Last Update Posted: 2017-09-28
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relatives	Clinical and environmental evaluation	-
Patients with schizophrenia	Clinical and environmental evaluation	-

Primary Outcome Measures

Name	Time	Method
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)	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	56 months, From March 2014 to November 2018

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France