Influence of Environmental Factors and Schizophrenia

NCT03296384 | Unknown

• 1 other identifier: P100134
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Schizophrenia; Relatives

Keywords

schizophrenia; environmental factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (2)

Patients with schizophrenia

OTHER

Other: Clinical and environmental evaluation

Relatives

OTHER

Other: Clinical and environmental evaluation

Interventions

Clinical and environmental evaluation OTHER

For schizophrenic's patients, specific assessment will be perform

Patients with schizophrenia; Relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients
• The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut national d'étude démographique (INED): collaborator
• CPN (INSERM U894) CH Sainte-Anne - Paris: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Fondation FondaMental: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Franck Schürhoff, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Pierre-Michel Llorca, MD PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franck Schürhoff, MD PhD

CONTACT

(0)1 49 81 30 50; franck.schurhoff@inserm.fr

Andrei Szoke, MD

CONTACT

(0)1 49 81 32 90; andrei.szoke@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 28, 2017
• Study Start: March 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

FR (1)