Influence of Environmental Factors and Schizophrenia

Relatives Clinical Trial

— Envschi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03296384
• Other study ID #: P100134
• 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
• 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

Related Conditions & MeSH terms

• Patients With Schizophrenia
• Relatives
• Schizophrenia

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 – Paris, Fondation FondaMental, Institut national d’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