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Influence of Environmental Factors and Schizophrenia (Envschi)

A

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Patients With Schizophrenia
Relatives

Treatments

Other: Clinical and environmental evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03296384
P100134

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 2 patient groups

Patients with schizophrenia
Other group
Treatment:
Other: Clinical and environmental evaluation
Relatives
Other group
Treatment:
Other: Clinical and environmental evaluation

Trial contacts and locations

1

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Central trial contact

Andrei Szoke, MD; Franck Schürhoff, MD PhD

Data sourced from clinicaltrials.gov

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