Evaluating the effectiveness of citalopram and sertraline in the treatment of depression with respect to the level of BDNF, IL-6, and cortisol in men and women with major depressive disorder: A randomized double-blinded clinical trial
Investigating the efficacy of citalopram and sertraline in depression according to BDNF, IL-6, and cortisol levels
Design
Randomized double blind clinical trial
Settings and conduct
This study will be performed on patients attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-60 years old - Based on DSM-V have a diagnosis of major depression (MDD) and their minimum severity of depression based on HDRS is 19. Exclusion criteria: Any other mental disorder in another axis - Serious suicidal thoughts (<2 in suicidal HDRS section) - Psychosis - History of ECT in recent two months - History of mania and hypomania - Thyroid dysfunctions - History of cardiovascular disease - Diabetes - Autoimmune disorders - Presence of active infection - Neurologic disorders like epilepsy and Alzheimer's disease - Liver disease - Kidney disease - Pregnant or lactating women
Intervention groups
Control group: women and men with major depressive disorder receiving citalopram (40 mg daily) for six weeks. Intervention group: women and men with major depressive disorder receiving sertraline (100 mg/day) for six weeks.
Main outcome variables
Severity of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N147
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of citalopram and sertraline in the treatment of depression with respect to the level of BDNF, IL-6, and cortisol in men and women with major depressive disorder: A randomized double-blinded clinical trial
Public title
Efficacy of citalopram and sertraline in depression according to BDNF, IL-6, and cortisol levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years old
Based on DSM-V have a diagnosis of major depression (MDD) and their minimum severity of depression based on HDRS is 19
Exclusion criteria:
Any other mental disorder in another axis
Serious suicidal thoughts (<2 in suicidal HDRS section)
Psychosis
History of ECT in recent two months
History of mania and hypomania
Thyroid dysfunctions
History of cardiovascular disease
Diabetes
Autoimmune disorders
Presence of active infection
Neurologic disorders like epilepsy and Alzheimer's disease
Liver disease
Kidney disease
Pregnant or lactating women
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-06-17, 1401/03/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.452
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Severity of depression
Timepoint
Weeks 0 , 4 , 8
Method of measurement
By Hamilton Depression Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Men and women with major depressive disorder receiving citalopram (40 mg daily) for six weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Men and women with major depressive disorder receiving sertraline (100 mg/day) for six weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5541 2222
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2023 to 2028
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof. Shahin Akhondzadeh
What processes are involved for a request to access data/document