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

NCT ID: NCT05395897

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2772093 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-12

Brief Summary

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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

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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).

Conditions

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Psychotropic Drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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New users

Users without any reimbursement for psychotropic drugs before the beginning of the coronavirus crisis.

No interventions assigned to this group

Actual or former users

Users without at least one reimbursement for psychotropic drugs before the beginning of the coronavirus crisis.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline VIGNEAU, Professor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes university hospital

Nantes, Loire-atlantique, France

Site Status

Countries

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France

Other Identifiers

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RC21_0409

Identifier Type: -

Identifier Source: org_study_id

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