Evaluation the response rate in major depressive disorder after taking sertraline as a predictive factor base on motor cortex magnetic brain stimulation.
Evaluation the response rate in major depressive disorder after taking sertraline as a predictive factor base on motor cortex brain stimulation.
Design
Clinical trial ؛based on community and practical ؛phase 2 on 48 patients
Settings and conduct
Depressed patients have their Motor Evoked Potential measured and re-measured after a dose of sertralin 2 hours later and then compared.
Participants/Inclusion and exclusion criteria
incluson :evaluation major depressive disorder Psychiatrist or Hamilton question
between 18-65 Age
question provided by the Having informed satisfaction and motivation to cooperate and participate in completing the researcher
No history of psychiatrist medication use in last two week
exclusion :If a person has a specific acute neurological disorder at the same time
Intervention groups
Patients are diagnosed with major depressive disorder and their MEP is measured and then they take a dose of sertraline and then MEP is measured again after 2 hours and then stimulates threshold is compared before and after sertraline.
Main outcome variables
Motor evoked potential
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100119003106N44
Registration date:2023-02-16, 1401/11/27
Registration timing:retrospective
Last update:2023-02-16, 1401/11/27
Update count:0
Registration date
2023-02-16, 1401/11/27
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
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the response rate in major depressive disorder after taking sertraline as a predictive factor base on motor cortex magnetic brain stimulation.
Public title
Evaluation the response rate in major depressive disorder after taking Sertraline as a predictive factor base on motor cortex magnetic brain stimulation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
evaluation major depressive disorder Psychiatrist or Hamilton 24 question
Age between 18-65
question provided by the Having informed satisfaction and motivation to cooperate and participate in completing the researcher
No history of psychiatrist medication use in last two week
Exclusion criteria:
If a person has a specific acute 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)
Not randomized
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 Islamic Azad university of Tehran medical sciences
Street address
No. 99, Yakhchal Street, Gholhak Dr. Shariati St.
City
TEHRAN
Province
Tehran
Postal code
1441933111
Approval date
2022-02-28, 1400/12/09
Ethics committee reference number
IR.IAU.TMU.REC.1400.325
Health conditions studied
1
Description of health condition studied
The effect of sertraline in major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Determining the Motor evoked potential of patients through transcranial magnetic stimulation
Timepoint
Before taking sertraline and 2 hours after taking sertraline
Method of measurement
Comparison of Motor evoked potential of patients before and after taking serteralin
Secondary outcomes
1
Description
Hamilton and Beck depression questionnaire
Timepoint
Before taking sertraline and after taking sertraline
Method of measurement
Comparison of Hamilton and beck depression score of patients before and after taking serteralin
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, confirmed by a psychiatrist and will be selected using the Hamilton and Beck questionnaire, and the amount of motor evoked potential will be measured for them after taking 100 mg of serteralin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mental health Atie clinic
Full name of responsible person
Dr. Reza Rostami
Street address
No 99 , yasaman alley , yakhchal street ,Gholhak,Dr shariati street ,tehran Iran
City
Tehran
Province
Tehran
Postal code
1441933111
Phone
+98 21 8401 2000
Email
rezaros@gmal.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad hashemian
Street address
No. 99 , Shariati St., Qolhak St., Yasaman
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
Research Unit of Azad Islamic University of Medical Sciences
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
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
Title and more details about the data/document
Evaluation the response rate in major depressive disorder after taking sertraline as a predictive factor base on motor cortex magnetic brain stimulation.
When the data will become available and for how long
Just after the articles publication.
To whom data/document is available
For all investigators.
Under which criteria data/document could be used
No more information.
From where data/document is obtainable
Applicants can refer to the department of clinical pharmacy faculty of pharmacy, Tehran medical science Islamic area university Dr. Hashemian or contact the researcher by sending email to mahsimamoosavandi1@gmail.com or calling 09127834959.
What processes are involved for a request to access data/document
the information. Applicant must commit themselves to mention the source. If the request is sent six months after the publication of research information the researcher will send the data to the requesting party by email within a week.