Status: Ongoing First registered on: 24/05/2019
Last updated on: 29/08/2020
1. Study identification
EU PAS Register NumberEUPAS29862
Official titleInfluence of social deprivation on psychotropic drugs dispensing in adults: a large cross-sectional population-based study in France
Study title acronymISDepPSY
Study typeObservational study
Brief description of the studyIntroduction: Links between lower socioeconomic position (SEP) and prevalence of common mental health disorders (CMHD) have been identified in the literature, and adequacy of treatments seems to differ according to SEP. We assume that lower SEP is associated with more psychotropic drugs consumption and more inadequate use. Primary objective: to assess correlation between the number of dispensing of anxiolytic and hypnotic drugs and social deprivation (EDI). Methods: Retrospective cross-sectional population-based study. Based on the joint use of French healthcare insurance population-based data on reimbursement of out-of-hospital care during the year 2012, which included 2,574,310 individuals and an ecological indicator of social deprivation in the Midi-Pyrénées region of France. Main outcomes and data of interest: - Number of distinct anxiolytic and hypnotic drugs (ATC: N05) dispensing. - Number of distinct antidepressant drugs (ATC: N06A) dispensing. - Adequacy with guidelines regarding psychotropic drug dispensing patterns among patients being dispensed at least one psychotropic drug, defined as: . Six or more distinct dispensing dates of antidepressant drugs (ATC: N06A), if any antidepressant drugs dispensing AND . Three or less distinct dispensing dates of anxiolytic drugs (ATC: N05BA) AND . Two or less distinct dispensing dates of hypnotic drugs (ATC: N05CD and N05CF) - European Deprivation Index (EDI): a validated ecological deprivation index that approaches SEP Statistical analysis: Univariate analyses (linear regression) and then multivariate analysis of the association between the number of anxiolytic and hypnotic drugs dispensed and EDI (primary objective), then other covariates and EDI (secondary objectives), will be performed to obtain correlation coefficients. If the assumptions for linear regression are not met, logistic regression will be performed to obtain Odds Ratios.
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 collection01/11/201901/11/2019
Start date of data analysis01/11/201901/12/2019
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 Guesde
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-562889048 
Alternative phone number33-561145606 
Fax number (incl. country code)33-562889084 
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 Guesde 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-562889048 
Alternative phone number33-561145606 
Fax number (incl. country code)33-562889084 
Email address marie-eve.rouge-bugat@univ-tlse3.fr 
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