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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