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

NCT04899206 | Withdrawn

• 1 other identifier: HUB-FC-2020-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACE Inhibitors; ARB; Hypertension; Depression

Keywords

ACEI; ARB; ACE; RAS; Angiotension; Depression; Hypertension

Outcome Measures

Primary Outcomes (2)

• Patients treated with antihypertensive drugs

  Number of patients under treatment with antihypertensive drugs

  3 years

• Patients treated with an antidepressant drug

  Number of patients under treatment with antidepressant drug

  3 years

Secondary Outcomes (7)

• Patients diagnosed with Hypertension

  3 years

• Patients diagnosed with Depression

  3 years

• Patients treated with ARBs

  3 years

• Patients treated with ACEIs

  3 years

• Patients treated with other antihypertensive drugs

  3 years

Study Arms (5)

ARBs only

Hypertensive patients under pharmacological treatment with ARBs

Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug

ACEIs only

Hypertensive patients under pharmacological treatment with ACEIs

Drug: With an Antidepressant Drug; Drug: Without an Antidepressant Drug

ARBs + ACEIs

Hypertensive patients under pharmacological treatment with ARBs and ACEIs

Drug: With an Antidepressant Drug; Drug: Without 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; Drug: Without 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; Drug: Without an Antidepressant Drug

Interventions

With an Antidepressant Drug DRUG

Current users of an antidepressant drug.

ACEIs only; ARBs + ACEIs; ARBs only; Angiotensin Agents and Other Antihypertensive Drugs; Other Antihypertensive Drugs

Without an Antidepressant Drug DRUG

Non-current users of an antidepressant drug.

ACEIs only; ARBs + ACEIs; ARBs only; Angiotensin Agents and Other Antihypertensive Drugs; Other Antihypertensive Drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Sebastian Videla: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Institut Català de la Salut: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

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MeSH Terms

Conditions

Hypertension; Depression

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Sebastián Videla, MD, PhD

  Head of the Clinical Research Support Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 38 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Clinical Research Support Unit

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: April 12, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

ES (1)