The effect of treatment with escitalopram on quality of life and hospitalization rate in depressed patients with systolic heart failure: a double blind randomized controlled trial
evaluation the effect of pharmacologic treatment of depression on the short-term prognosis of depressed patients with systolic heart failure
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 84 patients. The rand function of Excel software was used for randomization
Settings and conduct
The participants in the study at Imam Hossein Hospital in Tehran will complete the Hospital Anxiety and Depression Scale, the Patient Health Questionnaire, and the Minnesota Quality of Life Questionnaire. one group will be treated with citalopram at the rate of 20 mg for 8 weeks and the other group will be treated with placebo. Then the follow-up of the patients will be done along with physical examination again, and answering the quality of life questionnaire again after 8 weeks. .In screening, clinical history, physical examination and left ventricular systolic function will be evaluated. This study is double-blind. . The people participating in the study and the evaluators of the final outcome of the patients will not be aware of the drug or placebo.
Participants/Inclusion and exclusion criteria
The study population: includes patients referred to Imam Hossein Hospital in 1401-1402 who were admitted to the CCU department and had systolic heart failure and depression in the evaluations
Intervention groups
After checking the entry conditions of the participants in the study according to the entry and non-entry criteria, the candidate will be placed in one of the following 2 groups using a pre-planned random allocation:
Intervention group: taking 20 mg of S-citalopram orally manufactured by Abidi company for 8 weeks from the beginning of the study.
Placebo group: placebo consumption of orally manufactured by Abidi company for 8 weeks from the beginning of the study.
Main outcome variables
Quality of life, hospitalization rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230510058142N1
Registration date:2023-12-09, 1402/09/18
Registration timing:retrospective
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Farnaz Pourrajab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3431 4130
Email address
farnazpourrajab71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment with escitalopram on quality of life and hospitalization rate in depressed patients with systolic heart failure: a double blind randomized controlled trial
Public title
The effect of treatment with escitalopram on quality of life and hospitalization rate in depressed patients with systolic heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 30 to 75 years
Patients with left ventricular systolic dysfunction (left ventricular ejection fraction <0.40)
Clinical diagnosis of heart failure with at least one episode of dyspnea either with minimal activity or at rest
NYHA classIII or IV
Informed consent of patients
Exclusion criteria:
Previous history of intolerance to SSRI antidepressants
Bipolar or severe personality disorder
Severe suicidal thoughts
Recent dependence on alcohol or drugs
pregnancy
breastfeeding
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible people will be randomly assigned to one of the two groups to receive medicine or placebo with a ratio of 1:1. Randomization will be done automatically by creating random numbers in an Excel file and assigning people to two drug and placebo groups.The rand function of Excel software was used for randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. The medicine and placebo needed for the people participating in the study will be completely covered and indistinguishable form for use by patients. The people participating in the study and the evaluators of the final outcome of the patients will not be aware of the drug or placebo. The grouping of patients will be done based on the allocation of random numbers in the Excel file prepared by the researcher responsible for the study, and other people and patients will not know about the grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Zarafshan Ave, Qods Town,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.047
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
quality of life
Timepoint
At the beginning of the study and 8 weeks later
Method of measurement
Minnesota Standard Questionnaire
Secondary outcomes
1
Description
Hospitalization rate
Timepoint
The beginning of the study and 2 month later
Method of measurement
Patient files and Questionnaire
Intervention groups
1
Description
Intervention group: Taking 20 mg of es citalopram orally, manufactured by abidi company, for 8 weeks from the beginning of the study then Refer to a psychiatrist after the end of the study to continue antidepressant treatment
Category
Treatment - Drugs
2
Description
Control group: Taking placebo for 8 weeks, referring patients to a psychiatrist after the end of the intervention to start anti-depressant treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
farnaz pourrajab
Street address
Imam Hossein Hospital, Shahid Madani Street, Tehran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
farnazpourrajab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr afshin zarghi
Street address
Shahid Madani Ave,Imam Hossein hospital , Tehran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
farnazpourrajab71@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farnaz pourrajab
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shahid Madani Ave, Imam Hossein hospital, Tehran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
farnazpourrajab71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farnaz pourrajab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shahid Madani Ave, Imam Hossein hospital,Tehran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
farnazpourrajab71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
farnaz pourrajab
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Shahid Madani Ave,Imam Hossein hospital , Tehran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
farnazpourrajab71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available