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

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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

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