Last update : 02/06/2012 | Version : 1 | ID : 181
General | |
Identification | |
Detailed name | TREATMENT RESPONSE TO ANTIDEPRESSANTS IN MAJOR DEPRESSIVE DISORDER ACCORDING TO THE NUMBER OF PREVIOUS EPISODES IN A GENERAL PRACTICE SETTING, IN FRANCE |
Sign or acronym | RéPONSe |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°909515 |
General Aspects | |
Medical area |
General practice Psychology and psychiatry |
Others (details) | depression, major depressive episode (MDE) |
Keywords | response, treatment, antidepressant |
Scientific investigator(s) (Contact) | |
Name of the director | Crochard |
Surname | Anne |
Phone | +33 (0)1 79 41 28 51 |
acro@lundbeck.com | |
Organization | Lundbeck |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Laboratory LUNDBECK SAS |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Lundbeck SAS |
Organisation status |
Private |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Longitudinal study (except cohorts) |
Database recruitment is carried out by an intermediary |
A selection of health care professionals |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. |
A sample of general practionners was randomly selected from a qualified sampling frame of primary care physicians (CEGEDIM national file): sending of a mailing for a call for participating on a voluntary basis. Selection of patients: the first 4 patients consulting the general practitioner and meeting inclusion criteria were included in the cohort. |
Database objective | |
Main objective | Comparison response to treatment by antidepressants at 3 months in patients suffering from a major depressive episode (MDE) according to the number of prior episodes of EDM in general practice |
Inclusion criteria |
* Patient aged 18 years or older, * Patient suffering from a MDE (DSM IV criterion), * Patient for whom the physician initiates an antidepressant treatment |
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 | Metropolitan France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2010 |
Date of last collection (YYYY or MM/YYYY) | 2011 |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 10334 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Declarative data |
Clinical data (detail) |
Direct physical measures |
Declarative data (detail) |
Paper self-questionnaire |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity Quality of life/health perception |
Procedures | |
Data collection method | The physician collects the clinical information and gives the self-questionnaire to the patient at the time of the visit. |
Participant monitoring |
Yes |
Details on monitoring of participants | 3 months |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Publication in progress |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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