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

NCT05395897 | Completed

• 1 other identifier: RC21_0409
• Study Type: observational
• Target: 2,772,093
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotropic Drugs

Keywords

Psychotropic drugs, SARS-CoV-2, health impact assessment

Outcome Measures

Primary Outcomes (1)

• Trajectories of healthcare consumption (psychotropic drugs, consultations, hospitalizations)

  Trajectories will be defined as the succession of healthcare events. Multidimensional trajectories will be constructed taking into account the timing and concomitance of reimbursements

  2020-2021

Secondary Outcomes (1)

• Problematic use of psychotropic drugs

  2018-2021

Study Arms (2)

New users

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

Actual or former users

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A 10% random sample of the subjects identified in the SNDS, weighted on the region of residence.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes university hospital

Nantes, Loire-atlantique, 44093, France

Location

Study Officials

• Caroline VIGNEAU, Professor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 12, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

FR (1)