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Trial record 28 of 3315 for:    schizophrenia

Influence of Environmental Factors and Schizophrenia (Envschi)

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ClinicalTrials.gov Identifier: NCT03296384
Recruitment Status : Unknown
Verified September 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Patients With Schizophrenia Relatives Other: Clinical and environmental evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia
Actual Study Start Date : March 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Patients with schizophrenia Other: Clinical and environmental evaluation
For schizophrenic's patients, specific assessment will be perform

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296384


Contacts
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Contact: Franck Schürhoff, MD PhD (0)1 49 81 30 50 ext +33 franck.schurhoff@inserm.fr
Contact: Andrei Szoke, MD (0)1 49 81 32 90 ext +33 andrei.szoke@inserm.fr

Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
Investigators
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Principal Investigator: Franck Schürhoff, MD PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Pierre-Michel Llorca, MD PhD CHU de Clermont Ferrand

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03296384     History of Changes
Other Study ID Numbers: P100134
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
schizophrenia
environmental factors
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders