Comparison of the effectiveness of mirtazapine and citalopram on general health and quality of life in patients with major depression and breast cancer in the oncology ward
Comparison of the effectiveness of mirtazapine and citalopram on general health and quality of life in patients with major depression and breast cancer
Design
Sampling in this study will be easy and accessible. Samples will be randomly selected from patients with major depression based on the DSM-V criteria and breast cancer in stage 1-4 of the disease after surgery during chemotherapy and radiotherapy. Patients will be randomly assigned to two intervention groups of 21 patients treated with mirtazapine and citalopram.
Settings and conduct
Psychiatry, 5 Azar Hospital, Gorgan, clinical trial, drug therapy and assessment of general health and quality of life with relevant questionnaires, blinding by simple random method
Participants/Inclusion and exclusion criteria
1- People with breast cancer after radiotherapy surgery and undergoing chemotherapy or radiotherapy in stages 1 to 4 of disease progression
2- Age over 18 years and under 65 years
3- The level of education in middle school and higher
4- Existence of major depression criteria based on DSM-V criteria
Intervention groups
After the clinical interview, if there is a diagnosis of depression in the patient based on the DSM-V criteria, the patient enters the research project. After consultation with the hematology specialist, the patient will be randomly divided into one of the interventional categories of mirtazapine or citalopram. Patients in the mirtazapine group will receive 15 mg of mirtazapine daily, and patients in the citalopram group will receive 20 mg of citalopram daily. Patients in both groups will receive medication for 3 months and will be routinely asked about patient compliance during pre-scheduled visits and the results will be recorded in a pre-prepared checklist.
Main outcome variables
Comparison of the effect of mirtazapine and citalopram on general health and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054440N1
Registration date:2022-05-10, 1401/02/20
Registration timing:registered_while_recruiting
Last update:2022-05-10, 1401/02/20
Update count:0
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Zohreh Keivanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3222 3392
Email address
dr.z.keyvanlou@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mirtazapine and citalopram on general health and quality of life in patients with major depression and breast cancer in the oncology ward
Public title
Comparison of mirtazapine and citalopram in the treatment of depression in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females with breast cancer after radiotherapy surgery and undergoing chemotherapy or radiotherapy in stages 1 to 4 of disease progression
Age over 18 years and under 65 years
Middle school education level and higher
Existence of major depression criteria based on DSM-V criteria
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Divide into two groups with equal numbers by simple random method
Blinding (investigator's opinion)
Single blinded
Blinding description
Only treatment participants and Care providers are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
5 Azar St., 5 Azar Hospital, Psychiatric Department
City
Gorgan
Province
Golestan
Postal code
4917763681
Approval date
2021-07-25, 1400/05/03
Ethics committee reference number
IR.GOUMS.REC.1400.104
Health conditions studied
1
Description of health condition studied
Major Depression, Breast Cancer, Mirtazapine, Citalopram
ICD-10 code
C50 , F32
ICD-10 code description
Malignant neoplasm of breast, major depression
Primary outcomes
1
Description
Quality of life, general health
Timepoint
One and three months after starting treatment
Method of measurement
Questionnaire GHQ-28 and SF-36
Secondary outcomes
empty
Intervention groups
1
Description
After the clinical interview, if there is a diagnosis of depression in the patient based on the DSM-V criteria, the patient enters the research project. After consultation with the hematology specialist, the patient will be randomly divided into one of the interventional categories of mirtazapine or citalopram. Patients in the mirtazapine group will receive 15 mg of mirtazapine daily, and patients in the citalopram group will receive 20 mg of citalopram daily. Patients in both groups will receive medication for 3 months and will be routinely asked about patient compliance during pre-scheduled visits and the results will be recorded in a pre-prepared checklist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Department of Gorgan Martyrs Research and Training Center, Golestan University of Medical S
Full name of responsible person
Zohreh keyvanlou Shahrestanaki
Street address
5 Azar St.
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.z.keyvanlou@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Honarvar
Street address
5 Azar Street
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Keyvanlou Shahrestanaki
Position
Psychiatric Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
5 Azar Street
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.z.keyvanlou@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zohreh Keyvanlou Shahrestanaki
Position
Psychiatric Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
5 Azar St. 5 Azar Hospital
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.z.keyvanlou@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Zohreh Keyvanlou Shahrestanaki
Position
Psychiatric Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physiology
Street address
5 Azar St. 5 Azar Hospital
City
gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
Dr.z.keyvanlou@gmail.com
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
No - There is not 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
Questionnaire sf-36 and questionnaire GHQ-28
When the data will become available and for how long
starting in January 2023
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
No additional explanation.
From where data/document is obtainable
Dr.z.keyvanlou@gmail.com
What processes are involved for a request to access data/document