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Influence of Environmental Factors and Schizophrenia (Envschi)

Primary Purpose

Patients With Schizophrenia, Relatives

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and environmental evaluation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patients With Schizophrenia focused on measuring schizophrenia, environmental factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with schizophrenia

Relatives

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments

Full Information

First Posted
September 1, 2016
Last Updated
September 27, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut national d'étude démographique (INED), CPN (INSERM U894) CH Sainte-Anne - Paris, Institut National de la Santé Et de la Recherche Médicale, France, Fondation FondaMental, University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03296384
Brief Title
Influence of Environmental Factors and Schizophrenia
Acronym
Envschi
Official Title
Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut national d'étude démographique (INED), CPN (INSERM U894) CH Sainte-Anne - Paris, Institut National de la Santé Et de la Recherche Médicale, France, Fondation FondaMental, University Hospital, Clermont-Ferrand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Schizophrenia, Relatives
Keywords
schizophrenia, environmental factors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with schizophrenia
Arm Type
Other
Arm Title
Relatives
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Clinical and environmental evaluation
Intervention Description
For schizophrenic's patients, specific assessment will be perform
Primary Outcome Measure Information:
Title
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)
Time Frame
56 months, From March 2014 to November 2018
Title
The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE
Time Frame
56 months, From March 2014 to November 2018
Secondary Outcome Measure Information:
Title
The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments
Time Frame
56 months, From March 2014 to November 2018

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franck Schürhoff, MD PhD
Phone
(0)1 49 81 30 50
Ext
+33
Email
franck.schurhoff@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Andrei Szoke, MD
Phone
(0)1 49 81 32 90
Ext
+33
Email
andrei.szoke@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Schürhoff, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Michel Llorca, MD PhD
Organizational Affiliation
CHU de Clermont Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Influence of Environmental Factors and Schizophrenia

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