ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
NCT ID: NCT04899206
Last Updated: 2025-06-05
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
WITHDRAWN
Study Classification
OBSERVATIONAL
Study Start Date
2021-04-12
Study Completion Date
2025-12-20
Brief Summary
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A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
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Detailed Description
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Hypertension is a multifactorial disease and an important risk factor for cardiovascular and cerebrovascular diseases. Also, major depression is commonly found on these patients. Together, they represent a substantial burden for patients and their families, with an increased morbimortality and reduced life-quality. It also has a major social impact by increasing healthcare assistance demand and by affecting patients' daily-life productivity, therefore generating direct and indirect health-associated costs.
The Renin-Angiotensin System is one of the known pathways that modulate systemic and central nervous system inflammation. Basic research studies have shown ARBs-related allosteric changes on receptors implicated on the pathophysiology of schizophrenia and depression, and also a pharmacological reversal of depression-like behavior in rats after the administration of losartan. Human research studies have also presented evidence that points towards an antidepressant effect of some antihypertensive drugs.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).
Our secondary objectives are as follows:
I. For ARBs:
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ARBs.
2. To estimate the clearance of antidepressant drugs prescription in patients concomitantly treated with ARBs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ARBs.
II. For ACEIs:
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ACEIs.
2. To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with ACEIs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ACEIs.
III. For other antihypertensive drugs (i.e., non-angiotensin agents: CCBs, β-blockers, and diuretics):
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with other antihypertensive drugs (non-angiotensin agents).
2. To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with other antihypertensive drugs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with other antihypertensive drugs.
IV. To perform an exploratory comparative analysis among the different antihypertensive drugs sub-cohorts.
The protocol (Final Version: February 18th, 2021) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation- Committee, code HUB-FC-2020-01, date April 20th, 2021). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.
The Renin-Angiotensin System is one of the known pathways that modulate systemic and central nervous system inflammation. Basic research studies have shown ARBs-related allosteric changes on receptors implicated on the pathophysiology of schizophrenia and depression, and also a pharmacological reversal of depression-like behavior in rats after the administration of losartan. Human research studies have also presented evidence that points towards an antidepressant effect of some antihypertensive drugs.
A retrospective cohort study will be performed by analyzing data obtained from the Catalan Southern Metropolitan data warehouse system, which collects data from both hospitalized and primary care patients from the Bellvitge University Hospital's area of influence. The investigators will begin by gathering information only on patients treated with antihypertensive drugs, which then will be stratified in two groups: 1) Angiotensin Agents group; 2) Other Antihypertensive Agents (Non-Angiotensin Agents) group. Afterwards, a separated analysis will be performed to assess the effects of ARBs and ACEIs separately on the prescription of antidepressant drugs.
Our primary objective is to estimate the prevalence, incidence, and clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in hypertensive patients under treatment with angiotensin agents (ARBs and/or ACEIs).
Our secondary objectives are as follows:
I. For ARBs:
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ARBs.
2. To estimate the clearance of antidepressant drugs prescription in patients concomitantly treated with ARBs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ARBs.
II. For ACEIs:
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with ACEIs.
2. To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with ACEIs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with ACEIs.
III. For other antihypertensive drugs (i.e., non-angiotensin agents: CCBs, β-blockers, and diuretics):
1. To estimate the prevalence of antidepressant drugs prescription in hypertensive patients under treatment with other antihypertensive drugs (non-angiotensin agents).
2. To estimate the clearance (incidence of antidepressant drugs withdrawal) of antidepressant drugs prescription in patients concomitantly treated with other antihypertensive drugs and antidepressant drugs.
3. To estimate the incidence of antidepressant drugs initiation in patients with hypertension treated with other antihypertensive drugs.
IV. To perform an exploratory comparative analysis among the different antihypertensive drugs sub-cohorts.
The protocol (Final Version: February 18th, 2021) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation- Committee, code HUB-FC-2020-01, date April 20th, 2021). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.
Conditions
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ACE Inhibitors
ARB
Hypertension
Depression
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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ARBs only
Hypertensive patients under pharmacological treatment with ARBs
With an Antidepressant Drug
Intervention Type
DRUG
Current users of an antidepressant drug.
Without an Antidepressant Drug
Intervention Type
DRUG
Non-current users of an antidepressant drug.
ACEIs only
Hypertensive patients under pharmacological treatment with ACEIs
With an Antidepressant Drug
Intervention Type
DRUG
Current users of an antidepressant drug.
Without an Antidepressant Drug
Intervention Type
DRUG
Non-current users of an antidepressant drug.
ARBs + ACEIs
Hypertensive patients under pharmacological treatment with ARBs and ACEIs
With an Antidepressant Drug
Intervention Type
DRUG
Current users of an antidepressant drug.
Without an Antidepressant Drug
Intervention Type
DRUG
Non-current users of an antidepressant drug.
Other Antihypertensive Drugs
Hypertensive patients under pharmacological treatment with non-angiotensin agents (diuretics, calcium channel blockers and/or β-blockers alone or combined among them)
With an Antidepressant Drug
Intervention Type
DRUG
Current users of an antidepressant drug.
Without an Antidepressant Drug
Intervention Type
DRUG
Non-current users of an antidepressant drug.
Angiotensin Agents and Other Antihypertensive Drugs
Hypertensive patients under combined pharmacological treatment with Angiotensin Agents (ACEIs and/or ARBs) and Other Antihypertensives (non-angiotensin agents)
With an Antidepressant Drug
Intervention Type
DRUG
Current users of an antidepressant drug.
Without an Antidepressant Drug
Intervention Type
DRUG
Non-current users of an antidepressant drug.
Interventions
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With an Antidepressant Drug
Current users of an antidepressant drug.
Intervention Type
DRUG
Without an Antidepressant Drug
Non-current users of an antidepressant drug.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients that had an antihypertensive drug prescribed between January 1st, 2015 and December 31st, 2017, whose ATC codes can be obtained from the 'DATA WAREHOUSE' database
* Age ≥ 18 years old
* Both genders
* Patients with information available on the 'DATA WAREHOUSE' database
* Patients with a clinical visit or prescription done afterwards the date when the information for the study was last collected (this way we ensure that the patient included on the study remained alive after the end of the observation period)
* Age ≥ 18 years old
* Both genders
* Patients with information available on the 'DATA WAREHOUSE' database
* Patients with a clinical visit or prescription done afterwards the date when the information for the study was last collected (this way we ensure that the patient included on the study remained alive after the end of the observation period)
Exclusion Criteria
* Lack of information about the beginning of treatment with an antihypertensive and/or with an antidepressant drug.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Institut d'Investigació Biomèdica de Bellvitge
OTHER
Sponsor Role
collaborator
Institut Català de la Salut
OTHER
Sponsor Role
collaborator
Sebastian Videla
OTHER
Sponsor Role
lead
Responsible Party
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Sebastian Videla
Head of the Clinical Research Support Unit
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Sebastián Videla, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Head of the Clinical Research Support Unit
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
Site Status
Countries
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Spain
References
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Other Identifiers
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HUB-FC-2020-01
Identifier Type: -
Identifier Source: org_study_id
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