Influence of Environmental Factors and Schizophrenia (Envschi)

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

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.

Study Overview

• Status: Unknown
• Conditions: Relatives; Patients With Schizophrenia
• Intervention / Treatment: Other: Clinical and environmental evaluation

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Recruiting
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with schizophrenia	Other: Clinical and environmental evaluation; For schizophrenic's patients, specific assessment will be perform
Other: Relatives	Other: Clinical and environmental evaluation; For schizophrenic's patients, specific assessment will be perform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University Hospital, Clermont-Ferrand; Fondation FondaMental; Institut national d'étude démographique (INED); CPN (INSERM U894) CH Sainte-Anne - Paris
• Investigators: Principal Investigator: Franck Schürhoff, MD PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Pierre-Michel Llorca, MD PhD, CHU de Clermont Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: schizophrenia; environmental factors
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: P100134