Antidepressive AgentsNCT05356078
Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database
An observational study of Antidepressive Agents and Aged, run by University Hospital, Caen at 1 site in France.
Trial summary
Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Antidepressive Agents, Aged, Delirium
- What is being tested?
- Antidepressant
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2022to 3 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and over who presented with delirium on antidepressants
Who may be able to join
- be over 65 years old
- taking antidepressants
- to have presented delirium
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy, 14033
About this study
Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated.
Antidepressants are widely prescribed in the elderly because of the frequency of anxiety-depressive symptoms in this population, where there are high pharmacokinetic and pharmacodynamic variability.
Read more
However, the association between antidepressants and the risk of delirium remains poorly understood.
Based on the analysis from the World Health Organization global database, the main objective of this study is to investigate the association between the different classes of antidepressants and the occurrence of the " delirium " event reported in the database.
A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of delirium.
- Conditions
- Antidepressive Agents, Aged, Delirium
- Being tested
- Antidepressant
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
"Delirium" event reported in the World Health Organization global database in subjects aged over 65 years taking antidepressants, comparative analysis by antidepressant class
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the studied population
From the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, the investigators select all patients over 65 years old.
Then among them, the investigators report :
- Antidepressants use by class (Non-selective monoamine reuptake inhibitors, Selective serotonin reuptake inhibitors, Selective serotonin-norepinephrine reuptake Inhibitors, Alpha-2-adrenergic receptor antagonists, Monoamine oxidase inhibitors, other antidepressants)
- Delirium event
- Co-prescription (Opioids, Antipsychotics, Anxiolytics, Hynotics)
- Comorbidities (Constipation, acute retention of urine, hyponatraemia etc...)
Measured: 03/01/2022
Analysis of the association between antidepressant classes and delirium reporting, among subjects aged 65 or older
A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)
Measured: 03/01/2022
Secondary outcomes (3)
Analysis by age group
Investigators study the association between antidepressant classes and delirium reporting for the age group 65-74 and for the age group 75 and over.
A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)
Measured: 03/01/2022
Analysis of the co-reporting of delirium and hyponatraemia
Investigators study the association between antidepressant classes and co-reporting of delirium and hyponatraemia among subjects aged 65 or older.
A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities).
Measured: 03/01/2022
Analysis of the most prescribed antidepressant
Investigators study the association between most prescribed antidepressants and delirium reporting among patients aged 65 or older.
We identified most prescribed antidepressants as those with more than 1000 cases reported in VigiBase®.
A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities).
Measured: 03/01/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start3 Jan 2022
- Primary completion3 Feb 2022
- Study completion3 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antidepressive AgentsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356078
- Sponsor's protocol ID
- Pharmaco20220103
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minoc EM, Villain C, Benbrika S, Chretien B, Descatoire P, Heraudeau M, Sassier M, Pierre M, Martinaud O, Dolladille C, Lelong-Boulouard V. Association between antidepressant use and delirium in older adults: an analysis of the World Health Organization's global pharmacovigilance database. BMC Geriatr. 2024 Jul 12;24(1):600. doi: 10.1186/s12877-024-05022-0.
PubMed 38997635
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database
- ClinicalTrials.gov ID
- NCT05356078
- Acronym / sponsor ID
- Pharmaco20220103
- Conditions
- Antidepressive Agents, Aged, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Jun 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated.
Antidepressants are widely prescribed in the elderly because of the frequency of anxiety-depressive symptoms in this population, where there are high pharmacokinetic and pharmacodynamic variability.
However, the association between antidepressants and the risk of delirium remains poorly understood.
Based on the analysis from the World Health Organization global database, the main objective of this study is to investigate the association between the different classes of antidepressants and the occurrence of the " delirium " event reported in the database.
A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and over who presented with delirium on antidepressants
Key inclusion criteria (3 listed)
- be over 65 years old
- taking antidepressants
- to have presented delirium
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antidepressant"Delirium" event reported in the World Health Organization global database in subjects aged over 65 years taking antidepressants, comparative analysis by antidepressant class | Drug | – |
Primary outcome
Descriptive analysis of the studied population
Time frame: 03/01/2022
From the WORLD HEALTH ORGANIZATION Vigibase pharmacovigilance database, the investigators select all patients over 65 years old. Then among them, the investigators report : * Antidepressants use by class (Non-selective monoamine reuptake inhibitors, Selective serotonin reuptake inhibitors, Selective serotonin-norepinephrine reuptake Inhibitors, Alpha-2-adrenergic receptor antagonists, Monoamine oxidase inhibitors, other antidepressants) * Delirium event * Co-prescription (Opioids, Antipsychotics, Anxiolytics, Hynotics) * Comorbidities (Constipation, acute retention of urine, hyponatraemia etc...)
Analysis of the association between antidepressant classes and delirium reporting, among subjects aged 65 or older
Time frame: 03/01/2022
A disproportionality analysis is carried out in multivariate analysis, taking into account a certain number of confounding factors (co-prescriptions and comorbidities)
3 secondary outcomes
Analysis by age group
Time frame: 03/01/2022
Analysis of the co-reporting of delirium and hyponatraemia
Time frame: 03/01/2022
Analysis of the most prescribed antidepressant
Time frame: 03/01/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 38997635Minoc EM, Villain C, Benbrika S, Chretien B, Descatoire P, Heraudeau M, Sassier M, Pierre M, Martinaud O, Dolladille C, Lelong-Boulouard V. Association between antidepressant use and delirium in older adults: an analysis of the World Health Organization's global pharmacovigilance database. BMC Geriatr. 2024 Jul 12;24(1):600. doi: 10.1186/s12877-024-05022-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antidepressive Agents and Aged, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of the studied population (time frame: 03/01/2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.