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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03296384
Other study ID # P100134
Secondary ID
Status Recruiting
Phase N/A
First received September 1, 2016
Last updated September 27, 2017
Start date March 2014
Est. completion date November 2018

Study information

Verified date September 2017
Source Assistance Publique - Hôpitaux de Paris
Contact Franck Schürhoff, MD PhD
Phone (0)1 49 81 30 50
Email franck.schurhoff@inserm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date November 2018
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical and environmental evaluation
For schizophrenic's patients, specific assessment will be perform

Locations

Country Name City State
France Henri Mondor Hospital Creteil

Sponsors (6)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris CPN (INSERM U894) CH Sainte-Anne ā€“ Paris, Fondation FondaMental, Institut national dā€™étude démographique (INED), Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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