Clinical trial NCT05395897: ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use
Official title: ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotropic Drugs
Keywords: Psychotropic drugs, SARS-CoV-2, health impact assessment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 2772093
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A 10% random sample of the subjects identified in the SNDS, weighted on the region of residence.

Brief summary: The health crisis linked to the coronavirus has had a significant impact on the mental health. The question of the repercussion of this crisis on the consumption of psychotropic drugs is crucial. It is all the more true in France, which was already among the countries with the highest consumption of psychotropic drugs before the crisis. Indeed, an increase in the number of reimbursements for anxiolytic, hypnotic and antidepressant drugs has been highlighted in the context of the health crisis, using data from the health insurance database.

To enhance the understanding about the impacts of the health crisis on the use of psychotropic drugs, it is essential to characterize the evolution of the use at the individual level.

The main objective is to assess the impact of the coronavirus-related health crisis on the consumption of psychotropic drugs by studying the trajectories of reimbursements.

The secondary objective of the project is to evaluate the evolution of problematic consumption of psychotropic drugs in the context of the health crisis.

Detailed description: The project will allow studying the evolution of the use of psychotropics since the coronavirus-related health crisis according to the temporality of consumption (succession and/or concomitance of consumption) or their persistence over time.

This project has two major aims:

* Pharmacosurveillance: evaluation of the impact of psychotropic drug consumption in the context of the health crisis related to the coronavirus. The consumption of psychotropic drugs is a public health issue in France and concerns the entire general population. Even before the crisis, France was one of the countries in the world where the consumption of psychotropic drugs was the highest.
* Scientific: use of an innovative methodology for assessing the impact of pharmaco-epidemiology (trajectories based on reimbursement data).

Eligibility criteria: Inclusion Criteria:

* Subjects identified in the French National Healthcare Data System (SNDS) in 2018, 2019, 2020 and 2021 at national level, alive on 01/01/2018, age ≥ 16 years on 01/01/2020.

Exclusion Criteria:

* Institutionalization at least one day in a residential facility for dependent elderly people with an internal pharmacy in 2018, 2019, 2020 or 2021.

Primary outcomes:
measure: Trajectories of healthcare consumption (psychotropic drugs, consultations, hospitalizations)
timeFrame: 2020-2021
Secondary outcomes:
measure: Problematic use of psychotropic drugs
timeFrame: 2018-2021
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes university hospital
state: Loire-atlantique
Study officials:
affiliation: Nantes University Hospital
name: Caroline VIGNEAU, Professor
role: PRINCIPAL_INVESTIGATOR
References: