ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use

Completed

• Conditions: Psychotropic Drugs

• Registration Number: NCT05395897
• Lead Sponsor: Nantes University Hospital

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).

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2772093

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trajectories of healthcare consumption (psychotropic drugs, consultations, hospitalizations)	2020-2021	Trajectories will be defined as the succession of healthcare events. Multidimensional trajectories will be constructed taking into account the timing and concomitance of reimbursements

Secondary Outcome Measures

Name	Time	Method
Problematic use of psychotropic drugs	2018-2021	The evolution of indicators of problematic use for psychotropic drugs will be studied: doctor shopping, pharmacy shopping, overconsumption

Trial Locations

Locations (1)

Nantes university hospital; 🇫🇷 Nantes, Loire-atlantique, France