Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899206
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2021-05-18
Brief Title:
ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
Sponsor:
Sebastian Videla
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
ANGIOTENSIN AGENTS AND REDUCTION OF THE PRESCRIPTION OF ANTIDEPRESSANT DRUGS A RETROSPECTIVE COHORT STUDY USING REAL-WORLD DATA
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hospitals 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
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 Hospitals 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 andor 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 ie 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 Hospitals 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 andor 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None