Influence of Environmental Factors and Schizophrenia

NCT ID: NCT03296384

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Patients With Schizophrenia Relatives

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with schizophrenia

Group Type OTHER

Clinical and environmental evaluation

Intervention Type OTHER

For schizophrenic's patients, specific assessment will be perform

Relatives

Group Type OTHER

Clinical and environmental evaluation

Intervention Type OTHER

For schizophrenic's patients, specific assessment will be perform

Interventions

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Clinical and environmental evaluation

For schizophrenic's patients, specific assessment will be perform

Intervention Type OTHER

Eligibility Criteria

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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


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut national d'étude démographique (INED)

UNKNOWN

Sponsor Role collaborator

CPN (INSERM U894) CH Sainte-Anne - Paris

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Fondation FondaMental

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck Schürhoff, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Pierre-Michel Llorca, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Clermont-Ferrand

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Franck Schürhoff, MD PhD

Role: CONTACT

(0)1 49 81 30 50 ext. +33

Andrei Szoke, MD

Role: CONTACT

(0)1 49 81 32 90 ext. +33

Other Identifiers

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P100134

Identifier Type: -

Identifier Source: org_study_id