Evaluating the efficacy of mirtazapine versus sertraline on depression symptoms in patients undergoing hemodialysis: a double-blind randomized clinical trial
To evaluate the efficacy of mirtazapine versus sertraline on depression symptoms in patients undergoing hemodialysis
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Beheshti Hospital in Hamadan city on 54 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 5 years
Undergoing hemodialysis for at least 6 months
Being literate
Suffering from depression
Exclusion criteria:
Pregnancy or breastfeeding
Receiving anti-depressant and anti-anxiety medication in the last 3 months
Liver failure
Use of drugs or alcohol
Intervention groups
Intervention group:
Tablet mirtazapine 7.5 mg daily for one week and then 15 mg daily for 11 weeks
Control group:
Tablet sertraline 50 mg daily for one week and then 100 mg daily for 11 weeks
Main outcome variables
Primary outcome:
Depression score
Secondary outcome:
Quality of life score
Serum albumin level
Percentage of weight gain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N445
Registration date:2022-11-09, 1401/08/18
Registration timing:prospective
Last update:2022-11-09, 1401/08/18
Update count:0
Registration date
2022-11-09, 1401/08/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of mirtazapine versus sertraline on depression symptoms in patients undergoing hemodialysis: a double-blind randomized clinical trial
Public title
Evaluating the efficacy of mirtazapine versus sertraline on depression symptoms in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 5 years
Undergoing hemodialysis for at least 6 months
Being literate
Suffering from depression
Exclusion criteria:
Pregnancy or breastfeeding
Receiving anti-depressant and anti-anxiety medication in the last 3 months
Liver failure
Use of drugs or alcohol
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-10-29, 1401/08/07
Ethics committee reference number
IR.UMSHA.REC.1401.648
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
Depression score
Timepoint
In weeks 4, 8, and 12 after the treatment
Method of measurement
Using the Beck Inventory Questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
After week 12
Method of measurement
Using Global Quality of Life Scale
2
Description
Serum albumin level
Timepoint
After week 12
Method of measurement
By using laboratory test
3
Description
Percentage of weight gain
Timepoint
After week 12
Method of measurement
By using weights
Intervention groups
1
Description
Intervention group: Tablet mirtazapine 7.5 mg daily for one week and then 15 mg daily for 11 weeks
Category
Treatment - Drugs
2
Description
Control group: Tablet sertraline 50 mg daily for one week and then 100 mg daily for 11 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Shadieh Shariati
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
shadi.shariatyy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shadieh Shariati
Position
Student of Pharmacology
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shadi.shariatyy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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