Status: Ongoing First registered on: 24/12/2019
Last updated on: 29/08/2020
1. Study identification
EU PAS Register NumberEUPAS32925
Official titleInfluence of social deprivation on benzodiazepines and antidepressants drugs dispensing among children and adolescents: a large cross-sectional population-based study in France.
Study title acronym
Study typeObservational study
Brief description of the studyIn European studies, association between socio-economic indicators of precariousness and benzodiazepines misuse, or antidepressants has been found, but these studies targeted more specifically the adults. Some French studies dealing with mental health management of children were not specifically assessing the link between socioeconomic position (SEP) and psychotropic drugs use and/or adequacy as a primary objective, or SEP was not measured with an indicator specl. We assume that lower SEP is associated with an inadequacy to the recommendation of psychotropic drugs use among children and adolescent, regarding recommendations. Lower SEP should be associated with a greater number of benzodiazepines and antidepressants dispensing, at an individual level. Primary objective: To assess correlation between the number of benzodiazepines dispensing (anxiolytic and hypnotic drugs) and the European Deprivation Index (EDI). Cross-sectional population-based study, based on secondary data collection, from the joint use of the Health Insurance information system and a social deprivation index in the large French region of Midi-Pyrenees during the year 2012 will be performed. Persons, aged below 18, with the right to access, as of 31 December 2012, one of the three main health insurance schemes in the Midi-Pyrénées region of France will be included. It represents 540,295 individuals who are below 18 in the exhaustive regional database that included 2,574,310 individuals (after excluding 92,542 beneficiaries who died during the period of interest and 41,349 beneficiaries to whom no IRIS could be allocated) We will perform a comparative analyses between groups, an - Univariate analyses and multivariate analyses (linear regression) of the association between the number of benzodiazepines drugs dispensed and covariates. We expect to find an association between a higher social deprivation index and number of benzodiazepines and antidepressants dispensed at an individual level.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Professor
Last name Rougé-Bugat
First name Marie-Eve
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/12/2018
Start date of data collection15/01/202015/01/2020
Start date of data analysis15/01/202028/01/2020
Date of interim report, if expected
Date of final study report15/09/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
Otherself funding100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Rougé-Bugat
First name Marie-Eve
Address line 137 Allees Jules
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address marie-eve.rouge-bugat@univ-tlse3.fr
Public Enquiries
Title Professor 
Last name Rougé-Bugat 
First name Marie-Eve 
Address line 137 Allees Jules 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address marie-eve.rouge-bugat@univ-tlse3.fr 
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