The comparison of the efficacy of Agomelatine and Sertraline in treatment of depression symptoms in patients with heart failure in double-blind randomized clinical trial
Comparison of the efficacy of Agomelatine and Sertraline in treatment of depression symptoms in patients with heart failure
Design
Clinical trial without control group, with parallel groups, double-blind, randomized, 58 patients with a block size of 4 will be randomly assigned to two groups of 29 people.
Settings and conduct
The studied population is patients over 18 years of age who refer to the heart failure clinics of Babol University of Medical Sciences. Patients will be randomly divided into 2 intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, With heart failure, Willingness to participate in the study, depressive disorder based on the questionnaire
Exclusion criteria: Patient with cognitive impairment, Mental retardation, History of substance use, Bipolar disorder, Kidney/Liver failure, Any uncontrolled medical illness
Intervention groups
Intervention group 1: Treatment with sertraline (Soban Co) starts as a daily tablet with a dose of 50 mg, which can be increased up to a maximum of 200 mg according to the clinical response and side effects.
Intervention group 2: Treatment with agomelatine (Tekaje Co) is started as a daily tablet with a dose of 25 mg, which can be increased up to a maximum of 50 mg according to the clinical response and side effects.
Main outcome variables
Patient´s depressive condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170606034348N7
Registration date:2022-12-26, 1401/10/05
Registration timing:prospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 121 3171
Email address
a.hamidia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of Agomelatine and Sertraline in treatment of depression symptoms in patients with heart failure in double-blind randomized clinical trial
Public title
Treatment of depressive symptoms in patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
With heart failure
Depressive Disorder (Based on the questionnaire)
Willingness to participate in the study
Exclusion criteria:
Patient with cognitive impairment
Mental retardation
History of substance use
Bipolar disorder
Kidney/Liver failure
Any uncontrolled medical illness
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 29 people using blocks of 4 and a ratio of 1:1. Randomization will be done using Statistics and Sample Size android software. In order to hide the treatment process, each drug is assigned a random code corresponding to the sequence generated above, and only the random code is written on the cans of the drugs. After entering the patients into the study and assigning treatment to them, the code inserted on the medicine will be recorded on the patient's file.
Blinding (investigator's opinion)
Double blinded
Blinding description
Agomelatine (Tekaje Company) and Sertraline (Soban Company) are prepared and coded in identical containers without name labels, and are provided to the researcher based on random allocation by the design statistician. Therefore, none of the patients and the researcher will know about the assigned treatment and will not know until the end of the study. The opening of the codes is done at the end of the study or in special cases with the diagnosis of the treating doctor (in case of severe drug side effects) during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.MUBABOL.REC.1401.138
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
patient´s depressive condition
Timepoint
Before intervention (first visit) ,the end of the fourth week (second visit), the end of the eighth week (third visit), the end of the twelfth week (the fourth visit)
Method of measurement
BDI and Hamilton Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Sertraline group patients (Soban company) will receive one 50 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 200 mg).
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in the agomelatine group (Tekaje company) will receive one 25 mg tablet daily (depending on the patient's response, it is possible to increase the dose up to a maximum of 50 mg).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid specialized and super-specialized clinic of Babol
Full name of responsible person
Dr. Angela Hamidia
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
a.hamidia@mubabol.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Angela Hamidia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Yahyanejad hospital, Jomhoory Eslami street
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
angela_7633@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD