Patients With SchizophreniaEnvschiNCT03296384
Influence of Environmental Factors and Schizophrenia
A study testing Clinical and environmental evaluation in people with Patients With Schizophrenia and Relatives, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Schizophrenia, Relatives
- What is being tested?
- Clinical and environmental evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- Patients
- The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia
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.
Read more
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
- Being tested
- Clinical and environmental evaluation
- Keywords
- schizophrenia, environmental factors
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and environmental evaluationOther
For schizophrenic's patients, specific assessment will be perform
| Study group | Role | What they receive |
|---|---|---|
| Patients with schizophrenia | Other | Not described Receives: Other: Clinical and environmental evaluation |
| Relatives | Other | Not described Receives: Other: Clinical and environmental evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 56 months, From March 2014 to November 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startMar 2014
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Franck Schürhoff, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisPierre-Michel Llorca, MD PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296384
- Sponsor's protocol ID
- P100134
- Acronym
- Envschi
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia
- ClinicalTrials.gov ID
- NCT03296384
- Acronym / sponsor ID
- Envschi / P100134
- Conditions
- Patients With Schizophrenia, Relatives
- Keywords
- schizophrenia, environmental factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- 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
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Other | Other: Clinical and environmental evaluation |
| Relatives | Other | Other: Clinical and environmental evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- Patients
- The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and environmental evaluationFor schizophrenic's patients, specific assessment will be perform | Other | Patients with schizophrenia, Relatives |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Schürhoff, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Pierre-Michel Llorca, MD PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and environmental evaluation in people with Patients With Schizophrenia and Relatives, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franck Schürhoff, MD PhD ((0)1 49 81 30 50 ext. +33, franck.schurhoff@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.