Last update : 08/17/2016 | Version : 1 | ID : 60155
| General | |
| Identification | |
| Detailed name | Cohort of Alcohol-Dependent Patients Admitted for Withdrawal: Suicidal Behaviour Study |
| Sign or acronym | ECSA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 25/10/2006 |
| General Aspects | |
| Medical area |
Psychology and psychiatry |
| Pathology (details) | Alcoholism, suicidal risk, depression |
| Health determinants |
Addictions Lifestyle and behavior Social and psychosocial factors |
| Keywords | suicide attempt, healthcare users, health events, dependency |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gorwood |
| Surname | Philip |
| Address | 75014 PARIS |
| Phone | +33 (0)1 45 65 85 72 |
| p.gorwood@ch-sainte-anne.fr | |
| Unit | Unit 675 Psychiatry and Neuroscience Centre, Sainte Anne Hospital |
| Organization | Inserm - National Institute of Health and Medical Research |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC (hospital clinical research programme); clinical research delegation (DRC) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Inserm - National Institute of Health and Medical Research |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Inclusion method: Prospective
Inclusion cut-off date: 01/08/2009 Number of required subjects: [500-1000] Number details: 800 |
| Database objective | |
| Main objective |
General aim: To measure the impact of suicidal thoughts, behaviour and death in alcohol dependency.
Secondary aim: To assess clinical (psychiatric comorbidity), neuropsychological (computer IGT test) and genetic (blood sample) risk factors. |
| Inclusion criteria | Alcohol-dependent, admitted for withdrawal. |
| 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 |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Multicentric cohort throughout France (5 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2007 |
| Date of last collection (YYYY or MM/YYYY) | 09/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 750 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination: At baseline and during follow-up. Examination frequency: 1 (year). Information collected during clinical examination: Depression, dependence, etc. (all psychiatric disorders). |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Interview questionnaire: At baseline and during follow-up. Interview frequency: 2 to 3 (years). Information collected during interview: Diagnostic interview for genetic studies (DIGS): semi-structured questionnaire. Other information sheet: During study. Frequency of other information sheet: ONCE AT ANALYSIS COMPLETION (Yearly). Information collected through other information sheet: Vital status. Who completes the other information sheet? Friends or relatives and/or general practitioner. |
| Biological data (detail) | Type of samples collected: Blood (for DNA) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Plasma DNA |
| Details of biobank content | Biobank: Blood bank, DNA bank |
| Procedures | |
| Quality procedure(s) used | Interviews: online entry; clinical examinations: online entry; biological examinations: online entry; consistency request: after electronic data is entered; management of missing data: refer back to patient; physician reminder for follow-up visits? yes; subject reminder for follow-up visits? yes; patients are informed about the use of their data (written). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 2 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Can data be used by academic teams? No. Can data be used by industrial teams? No. |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
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