Influence of social deprivation on psychotropic drugs dispensing in adults: a large cross-sectional population-based study in France (ISDepPSY)

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Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36959
• EU PAS number:
  EUPAS29862
• Study ID:
  36959
• Official title and acronym:
  Influence of social deprivation on psychotropic drugs dispensing in adults: a large cross-sectional population-based study in France (ISDepPSY)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Introduction: 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 dispensingAND. 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 SEPStatistical 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Toulouse III

France

INSERM 1027

Study timelines

Date when funding contract was signed

Actual: 10/12/2018

Study start date

Planned: 01/11/2019

Actual: 01/11/2019

Data analysis start date

Planned: 01/11/2019

Actual: 01/12/2019

Date of final study report

Planned: 15/09/2020

Sources of funding

Other

More details on funding

self-funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable