Last update : 01/31/2013 | Version : 1 | ID : 5468
| General | |
| Identification | |
| Detailed name | Predictive character of the total cholesterol threshold : a possible association with suicidal behaviour |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n° 1571206, CPP: 120202sc (06/03/2012) |
| General Aspects | |
| Medical area |
Biology Endocrinology and metabolism Psychology and psychiatry |
| Health determinants |
Nutrition |
| Others (details) | Mood disorders, suicide behaviour, cholesterol |
| Keywords | cholesterol |
| Scientific investigator(s) (Contact) | |
| Name of the director | Courtet |
| Surname | Philippe |
| Address | Hôpital la Colombière, Pavillon 42 39 avenue Charles Flahault B.P. 34493 34093 Montpellier - Cedex 5 - France |
| Phone | +33 (0)4 99 61 45 60 |
| p-courtet@chu-montpellier.fr | |
| Unit |
U 1061 : Neuropsychiatrie : Recherche épidémiologique et clinique Equipe 2 : Comportement suicidaire |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | CHU Montpellier |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | CHU Montpellier : promoteur |
| Organisation status |
Public |
| 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 care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | all subjects meeting criteria and agreeing to participate are included, no randomization |
| Database objective | |
| Main objective | Studying cholesterol rate as a predictor of the occurrence of suicidal behaviour at 18 months in the context of a depressive episode |
| Inclusion criteria | Adults, meet DSM-IV criteria for a major depressive episode |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Hérault |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 95 individus fin 2012 - Prévision: 555 patients 95 individuals end 2012 - Prediction: 555 patients |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Biological data (detail) | complete blood count, coagulation, ionogram, renal and liver function, thyroid function, fasting blood glucose, lipid profile, BHCG Women |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Serum and DNA. The samples will be stored for 30 years |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Clinical data are collected during consultations at 1, 3, 6, 12 and 18 months and biological data at 6, 12 and 18 months |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 5 visits over a period of 18 months (repeated clinical and biological evaluations) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be available to other researchers in the context of ancillary work (after agreement of Prof. Courtet ) |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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