Last update : 08/17/2016 | Version : 1 | ID : 73234
General | |
Identification | |
Detailed name | Cohort of Patients with Schizophrenia |
Sign or acronym | FACE-SZ |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval |
General Aspects | |
Medical area |
Psychology and psychiatry |
Pathology (details) | Schizophrenia |
Health determinants |
Addictions Healthcare system and access to health care services Lifestyle and behavior Medicine Occupation Social and psychosocial factors |
Keywords | translational research, schizophrenia, prevention, screening, treatment, care |
Scientific investigator(s) (Contact) | |
Name of the director | Schurhoff |
Surname | Franck |
franck.schurhoff@inserm.fr | |
Unit | Inserm, U955, Psychopathology and Psychiatric Disorder Genetics |
Organization | Fondation FondaMental, Inserm, Henri-Mondor university hospitals, AP-HP (Paris Public Hospitals) |
Name of the director | Fond |
Surname | Guillaume |
guillaume.fond@gmail.com | |
Unit | Inserm, U955, Psychopathology and Psychiatric Disorder Genetics |
Organization | Fondation FondaMental, Inserm, Henri-Mondor university hospitals, AP-HP (Paris Public Hospitals) |
Collaborations | |
Participation in projects, networks and consortia |
Yes |
Details | EU-GEI project (European Network of National Schizophrenia Networks studying Gene-Environment Interactions), OPTIMISE project (Optimization of Treatment and Management of Schizophrenia in Europe) |
Funding | |
Funding status |
Public |
Details | FondaMental foundation, INSERM, ANR-11-IDEX-0004 and ANR-10-COHO-10-01 |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | FondaMental foundation |
Organisation status |
Public |
Presence of scientific or steering committees |
Yes |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is is made on the basis of: |
Another treatment or procedure |
Database recruitment is carried out as part of an interventional study |
No |
Database objective | |
Main objective |
Aims are:
– to accelerate access to specialists for patients with schizophrenia as well as those at risk; – to foster a personalised medical approach through a systematic and thorough investigation of schizophrenia in order to improve detection and to prevent psychiatric and somatic comorbidity; to provide personalised care recommendations from a pharmacological, psychosocial and lifestyle standpoint; to prospectively assess the impact of treatments recommended to the individual and to identify relapse risk factors; – to reduce the time periods between the onset of disorders, accurate diagnoses and the introduction of suitable treatment; – to improve consistency between evidence-based medical guidelines and clinical practice; – to communicate expertise and skills using new diagnostic tools and treatment strategies. |
Inclusion criteria | Patients with schizophrenia in one of 10 participating centres. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2007 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 603 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Declarative data Biological data |
Clinical data (detail) |
Medical registration |
Details of collected clinical data | Social and demographic data (age, sex, marital status, education level, number of children), economic and medical data (Global Assessment of Functioning Scale, Quality of Life: S-QoL, work status and number of days worked in the last year, income, number of consultations during the year excluding psychiatric, number of emergency admissions, dental care, Personal and Social Performance Scale (PSP)), symptom history and progression (Positive And Negative Symptoms Scale (PANSS), number and duration of psychiatric hospital admissions, age and duration of first admission, age and duration of initial psychiatric treatment, aggressive behaviour, CGI: Clinical Global Impression), mood (Calgary Depression Score (CDSS hetero-questionnaires), Young Mania Rating Scale (YMRS), suicide), psychiatric comorbidity and risk factors (anxiety, eating disorders, family history, Childhood Trauma Questionnaire (CTQ), compulsions, etc.), addictions (drugs, tobacco, alcohol, internet, gambling), somatic comorbidity and anthropometric data. |
Declarative data (detail) |
Face to face interview |
Biological data (detail) | Full blood test; medication dosage; C-reactive protein; liver enzymes; TG-HDL-LDL; TSH; electrolytes; ferritin and prolactin levels |
Presence of a biobank |
Yes |
Contents of biobank |
Whole blood |
Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
Procedures | |
Data collection method | Through e-schizo© application developed by the Fondation FondaMental |
Participant monitoring |
Yes |
Details on monitoring of participants | The onset of significant changes are recorded every year (for 5 years), as well as clinical progression, hospital stays and/or sick leave. Negative, positive symptomatology; cognitive function; residual symptoms; mood; suicide attempts; professional and social impact; resource usage; treatment (including side effects and treatment adherence); quality of sleep; physical activity and insight are monitored. |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://www.fondation-fondamental.org/page_dyn.php?mytabsmenu=4&lang=FR&page_id=MDAwMDAwMDAzOA== |
Link to the document | http://tinyurl.com/PUBMED-FACE-SZ |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) |
Procedure for FondaMental network members who wish to access the FACE database:
1. Complete a summary FACE database request form and lexicon and send to face@fondation-fondamental.org. 2. After this submission, two documents will be sent: FACE lexicon (list of all available items) and FACE summary (data classified by main themes) regarding the specific illness. 3. The file to complete for retrieval requests consists of the following 3 items: – FACE database retrieval request form (completed and signed) – Letter of engagement (completed and signed) – Lexicon (with requested items checked) This form shall be sent to: face@fondation-fondamental.org |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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