SurPass - Family, social and professional disability in major depressive disorder patients starting a treatment with antidepressant
Head :
CROCHARD Anne, Lundbeck
Last update : 10/14/2013 | Version : 1 | ID : 183
| General | |
| Identification | |
| Detailed name | Family, social and professional disability in major depressive disorder patients starting a treatment with antidepressant |
| Sign or acronym | SurPass |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Demande d'autorisation CNIL n°909245 |
| General Aspects | |
| Medical area |
Psychology and psychiatry |
| Health determinants |
Occupation Social and psychosocial factors |
| Others (details) | Depression |
| Keywords | Antidepressants, functional effect, psychiatry |
| Scientific investigator(s) (Contact) | |
| Name of the director | CROCHARD |
| Surname | Anne |
| Address | 37-45 quai du Président Roosevelt 92445 Issy-les-Moulineaux Cedex |
| Phone | +33 (0)1 79 41 28 51 |
| acro@lundbeck.com | |
| Unit | Lundbeck |
| Organization | Lundbeck |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | 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 is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Psychiatrists selection: mailing of invitation letter sent to the whole liberal or mixed French psychiatrists. Patients selection: the first 5 patients seen by the psychiatrist and meeting inclusion criteria. |
| Database objective | |
| Main objective | Identify, in a cohort of major depressive disorder patients starting a treatment with any antidepressant to be followed for 6 months in a outpatient psychiatric setting, the predictive factors of an evolution of their family, social and professional disability and to establish a typology of patients according to their evolutive profile at 6 months after treatment initiation. |
| Inclusion criteria | 18 years old or more patients who suffer from a major depressive episode according to DSM-IV, starting an antidepressants treatment in an outpatient psychiatric setting; patients which can be followed for 6 months; patients able to communicate and self-evaluate |
| 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 | 4 300 |
| 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 | Data collected during spontaneous patients visits at inclusion and then at about 2 and 6 months. Data collected during each visit consists into a Sheehan disability scale at inclusion and at 6 months visits, filled by the patients, and a MADRS scale (depression severity) filled by the investigator. Patients meeting eligibility criteria and not included in the study are inscribed into a non-inclusion register which will allow to verify the representativeness of population included in the study. This register needs to be completed until the effective inclusion of 4 to 5 patients in the cohort. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 6 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 expected in a journal with reading committee |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
