CClinicalTrials.gg
Status unknownNCT03296384EnvschiUpdated Sep 28, 2017

Influence of Environmental Factors and Schizophrenia

An interventional study of Clinical and environmental evaluation in Patients With Schizophrenia and Relatives, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients With Schizophrenia
  • Relatives

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Keywords

  • schizophrenia
  • environmental factors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

Patients

  • The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Other
    Patients with schizophrenia

    Other: Clinical and environmental evaluation

  • Other
    Relatives

    Other: Clinical and environmental evaluation

Interventions

  • OtherClinical and environmental evaluation

    For schizophrenic's patients, specific assessment will be perform

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 56 months, From March 2014 to November 2018

  2. The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE

    Time frame: 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

    Time frame: 56 months, From March 2014 to November 2018

06

Study locations

1 of 1 sites recruiting
  • Henri Mondor Hospital
    Creteil, 94010, France
    Recruiting
07

Registry details

Key details

Study ID
NCT03296384
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut national d'étude démographique (INED), CPN (INSERM U894) CH Sainte-Anne - Paris, Institut National de la Santé Et de la Recherche Médicale, France, Fondation FondaMental, University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Mar 2014
Primary completion
Nov 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Sep 28, 2017

Study contacts

Franck Schürhoff, MD PhD
Contact
franck.schurhoff@inserm.fr
(0)1 49 81 30 50 ext. +33
Andrei Szoke, MD
Contact
andrei.szoke@inserm.fr
(0)1 49 81 32 90 ext. +33
Franck Schürhoff, MD PhD
principal investigator · Assistance Publique - Hôpitaux de Paris
Pierre-Michel Llorca, MD PhD
principal investigator · CHU de Clermont-Ferrand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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