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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05395897
Recruitment Status : Active, not recruiting
First Posted : May 27, 2022
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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.


Condition or disease
Psychotropic Drugs

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 Design
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Study Type : Observational
Actual Enrollment : 2772093 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use
Actual Study Start Date : January 1, 2023
Actual Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Tornadoes

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Trajectories of healthcare consumption (psychotropic drugs, consultations, hospitalizations) [ Time Frame: 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 :
  1. Problematic use of psychotropic drugs [ Time Frame: 2018-2021 ]
    The evolution of indicators of problematic use for psychotropic drugs will be studied: doctor shopping, pharmacy shopping, overconsumption


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A 10% random sample of the subjects identified in the SNDS, weighted on the region of residence.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05395897


Locations
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France
Nantes university hospital
Nantes, Loire-atlantique, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Caroline VIGNEAU, Professor Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT05395897    
Other Study ID Numbers: RC21_0409
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Psychotropic drugs, SARS-CoV-2, health impact assessment
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections