Study identification

PURI

https://redirect.ema.europa.eu/resource/41686

EU PAS number

EUPAS32925

Study ID

41686

Official title and acronym

Influence of social deprivation on benzodiazepines and antidepressants drugs dispensing among children and adolescents: a large cross-sectional population-based study in France

DARWIN EU® study

No

Study countries

France

Study description

In 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.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Marie-Eve Rougé-Bugat

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Self funding
Study protocol
Initial protocol

Research protocol-2

English (524.17 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable