Evaluation of the response rate in major depressive disorder after taking citalopram as a predictive factor base on motor cortex magnetic brain stimulation.
Determination of response rate in major depressive disorder after taking citalopram as a predictive factor base on motor cortex magnetic brain stimulation.
Design
Clinical trial ؛based on community and practical ؛phase 2 on 48 patients
Settings and conduct
48 patients with major depression confirmed by a psychiatrist in the Atiye Derakhshan Clinic. The patients will the Hamilton Depression Questionnaire after obtaining their written consent and assuring them of the confidentiality of their information.The motor evoked potential will be recorded using an electromyography device and using a TMS device, then they will be given a dose of citalopram, and then motor evoked potential will be checked again at a time interval of 2 hours. It will be registered and the drug treatment of patients with daily citalopram will continue until 4 weeks later and after that the Hamilton questionnaire will be filled again.
Participants/Inclusion and exclusion criteria
incluson :evaluation major depressive disorder Psychiatrist or Hamilton question
between 18-65 Age
Having informed satisfaction and motivation to cooperate
No history of psychiatrist medication use in last two week
exclusion :Unwillingness to continue cooperating in the study and not completing the questionnaire If a person has a specific acute neurological disorder at the same time
Intervention groups
48 patients with major depression in the age group of 18 to 65 years will be selected by a psychiatrist or by using the Hamilton and beck and their motor evoked potential will be measured an EMG device and using TMS will be recorded, then they will be given a dose of citalopram, and then their MEP will be checked and recorded again at 2-hour intervals, and patients will be treated with citalopram daily for 4 weeks. then the Hamilton questionnaire will be filled again
Main outcome variables
Motor evoked potential
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100119003106N43
Registration date:2023-02-09, 1401/11/20
Registration timing:retrospective
Last update:2023-02-09, 1401/11/20
Update count:0
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-01-31, 1401/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the response rate in major depressive disorder after taking citalopram as a predictive factor base on motor cortex magnetic brain stimulation.
Public title
Evaluation of the response rate in major depressive disorder after taking citalopram as a predictive factor base on motor cortex magnetic brain stimulation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depression by a psychiatrist or by using Hamilton's 24-question questionnaire
Age 18-65 years old
Having written informed consent and and incentive to cooperate and participate in completing the questionnaires provided by the researcher
Not having a history of taking psychiatric drugs in the last 2 weeks
Exclusion criteria:
Unwillingness to continue cooperating in the study and not completing the questionnaire
If the person is suffering from a specific neurological/psychological disorder at the same time
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Medical sciences
Street address
No. 99, Yakhchal street, Gholhak, Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2022-09-26, 1401/07/04
Ethics committee reference number
IR.IAU.TMU.REC.1401.220
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
Primary outcomes
1
Description
Determining the MEP of patients through TMS
Timepoint
Before taking citalopram and 2 hours after taking citalopram
Method of measurement
Comparison of MEP of patients before and after taking citalopram
Secondary outcomes
1
Description
Hamilton and Beck depression questionnaire
Timepoint
Before taking citalopram and after taking citalopram
Method of measurement
Comparison of Hamilton and beck depression score of patients before and after taking citalopram
Intervention groups
1
Description
Intervention group :48 patients with major depression in the age group of 18 to 65 years will be selected by a psychiatrist or by using the Hamilton and beck questionnaire and the amount of motor evoked potential will be measured for them before taking the drug.
Category
Treatment - Drugs
2
Description
Control group :Including 48 patients with major depression in the age group of 18 to 65 years approved by a psychiatrist will be selected using the Hamilton and beck questionnaire and the amount of motor evoked potential will be measured for them after taking 20mg citalopram drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiye mental health clinic
Full name of responsible person
Dr.Reza Rostami
Street address
No.23, Valinezhad St., Vanak
City
Tehran
Province
Tehran
Postal code
1969713663
Phone
+98 21 8401 2000
Email
rezaros@gmail.com
Web page address
https://atiehclinic.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Farshad Hashemian
Street address
No. 99, Yasaman Alley., Yakhchal street., Gholhak., Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
Hashemian.f@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Katayoun kiyanipour
Position
Pharm.D.candidate
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99 , Yasaman Alley., Yakhchal street., Gholhak., Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 4449 7295
Email
Katayun.kiyanipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Katayoun keyanipour
Position
Pharm.D.candidate
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99 , Yasaman Alley., Yakhchal street., Gholhak., Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 4449 7295
Email
Katayun.kiyanipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
katayoun kiyanipour
Position
Pharm.D.candidate
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99 , Yasaman Alley., Yakhchal street., Gholhak., Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 4449 7295
Email
Katayun.kiyanipour@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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Age and gender of patients' demographic information as well as the results and questionnaire containing patients' symptoms before and at the end of the treatment period can be shared by removing the individual characteristics of the patients.
When the data will become available and for how long
The release time of the documents and files is after the completion of the project and in the spring of 1402.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
By observing the ethical principles of information concealment, the documents and all the checks carried out on the information can be published.
From where data/document is obtainable
Katayun.kiyanipour@gmail.com
What processes are involved for a request to access data/document