In the random block method, people are divided into two groups, (total 300 people) and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher. The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of surgery. Also, the analyzer is not aware of the group in which the patient is placed.
Settings and conduct
By random block method, patients referred to Al-Zahra Hospital are divided into two groups, and then medication is administered by the clinical caregiver with a specific code and given to the researcher. The researcher has evaluated the patients and the patients are not aware of the type of drug used. the analyzer is not aware of the group in which the patient is placed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with a consciousness coefficient between 9 and 13, Conscious consent, Complete recovery from trauma 4 weeks after the incident Patients with a history of mood disorder must be in complete remission for at least 1 year after discontinuation of treatment.
Exclusion Criteria: Patients with persistent depression or any other mood disorder based on doctor's definitive diagnosis, Pregnant women or women who plan to become pregnant during the study period Previous, history of allergy to Citalopramin, Complex and debilitating underlying disease such as cancer, advanced heart failure
Intervention groups
In the Citalopram intervention group, 10 mg per day is prescribed for the first 3 days, then it is increased to 20 mg per day.Control group, They will receive a placebo (from an ineffective substance made in the Faculty of Pharmacy similar to citalopram daily for 90 days) just like the case group.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N9
Registration date:2024-08-07, 1403/05/17
Registration timing:prospective
Last update:2024-08-07, 1403/05/17
Update count:0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Citalopramin preventing depression in patients with moderate Traumatic brain injury
Public title
Citalopramin preventing depression in moderate TBI
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a consciousness coefficient between 9 and 13
Conscious consent of first -degree companions to enter the study
Complete recovery from trauma 4 weeks after the incident
Patients with a history of mood disorder must be in complete remission for at least 1 year after discontinuation of treatment
Exclusion criteria:
Patients with persistent depression or any other mood disorder based on medical records and doctor's definitive diagnosis
Pregnant women or women who plan to become pregnant during the study period
Previous history of allergy to Citalopramin
Complex and debilitating underlying disease such as cancer, advanced heart failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Easy sampling methods from those who are eligible to enter the study are randomly divided into two groups of cases and control. In this study, the segmentation of individuals is performed as a quadruple block. In this method A reflects the person who receives the intervention and B represents the person in the control group. Considering the four -block block, we give the AABB Code 0, to the ABAB Code 1, to ABBA Code 2, to BAAB Code 3, to BBAA Code 4 and BABA Code 5 to 9. Then, using the random numbers table, select the starting point randomly and then consider the numbers in a row or column. Considering the order of the table numbers, we replace each number we have hit. Finally, 3 people will be divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the random block method, people are divided into two groups, and then medication is administered by the clinical caregiver with a specific code for them, and it is provided to the researcher (student). The researcher evaluates the patients using a questionnaire and records the results based on the patient code. Patients are also not aware of the type of medicine they are taking. Also, the analyzer is not aware of the group in which the patient is placed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-07-25, 1403/05/04
Ethics committee reference number
IR.MUI.MED.REC.1403.156
Health conditions studied
1
Description of health condition studied
Moderate brain trauma
ICD-10 code
Diffuse tr
ICD-10 code description
S06.2
Primary outcomes
1
Description
Prevention of depression
Timepoint
One, three and 6 months after the injury
Method of measurement
Glasgow coma scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the citalopram intervention group were prescribed 10 mg per day for the first 3 days, then increased to 20 mg per day.
Category
Prevention
2
Description
Control group: They will receive a placebo (from an ineffective substance made in the Faculty of Pharmacy similar to citalopram daily for 90 days) just like the case group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Mehdi Shafiei
Street address
Al-Zahra Hospital, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 310 1971
Email
Mehdishafiei82@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Shafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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