ITMO public health
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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