ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS: A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA

June 2, 2025 updated by: Sebastian Videla
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • L'Hospitalet De Llobregat, Catalonia, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with antihypertensive drugs within the Bellvitge University Hospital's influence area (Barcelona's southern metropolitan area).

Description

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)

Exclusion Criteria:

  • Lack of information about the beginning of treatment with an antihypertensive and/or with an antidepressant drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARBs only
Hypertensive patients under pharmacological treatment with ARBs
Drug: With an Antidepressant Drug
Current users of an antidepressant drug.
Drug: Without an Antidepressant Drug
Non-current users of an antidepressant drug.
ACEIs only
Hypertensive patients under pharmacological treatment with ACEIs
Drug: With an Antidepressant Drug
Current users of an antidepressant drug.
Drug: Without an Antidepressant Drug
Non-current users of an antidepressant drug.
ARBs + ACEIs
Hypertensive patients under pharmacological treatment with ARBs and ACEIs
Drug: With an Antidepressant Drug
Current users of an antidepressant drug.
Drug: Without an Antidepressant 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)
Drug: With an Antidepressant Drug
Current users of an antidepressant drug.
Drug: Without an Antidepressant 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)
Drug: With an Antidepressant Drug
Current users of an antidepressant drug.
Drug: Without an Antidepressant Drug
Non-current users of an antidepressant drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients treated with antihypertensive drugs
Time Frame: 3 years
Number of patients under treatment with antihypertensive drugs
3 years
Patients treated with an antidepressant drug
Time Frame: 3 years
Number of patients under treatment with antidepressant drug
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients diagnosed with Hypertension
Time Frame: 3 years
Number of patients diagnosed with Hypertension
3 years
Patients diagnosed with Depression
Time Frame: 3 years
Number of patients diagnosed with Depression
3 years
Patients treated with ARBs
Time Frame: 3 years
Number of patients treated with ARBs
3 years
Patients treated with ACEIs
Time Frame: 3 years
Number of patients treated with ACEIs
3 years
Patients treated with other antihypertensive drugs
Time Frame: 3 years
Number of patients treated with other antihypertensive drugs (i.e., non-ARBs and non-ACEIs).
3 years
Patients treated with Amitriptyline
Time Frame: 3 years
Number of patients treated with Amitriptyline, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice.
3 years
Patients treated with Duloxetine
Time Frame: 3 years
Number of patients treated with Duloxetine, since this is an antidepressant drug commonly used to treat neuropathic pain in our usual practice.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebastian Videla

Collaborators

Institut d'Investigació Biomèdica de Bellvitge
Institut Català de la Salut

Investigators

  • Principal Investigator: Sebastián Videla, MD, PhD, Head of the Clinical Research Support Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

December 20, 2021

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB-FC-2020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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