Additive effect of Citicoline on conventional treatment of Bipolar in curent manic episode
Design
35patient diagnosed with Bipolar Disorder in manic phase treated treated with one dose of 250 mg/kg of Citicolin for 2 weeks and 35 patients in the control group that were receiving placebo. mood disorders was evaluated by YMRS. by the way both groups were treated with the standard treatment of Bipolar Disorder.
Settings and conduct
This clinical trial will be done in the psychiatry ward of Sina Farshchian hospital 35 patient diagnosed with bipolar disorder in manic phase treated with one dose of 250 mg/kg of Citicolin for 2 weeks and 35 patients in the control group that were receiving placebo mood disorders was evaluated by YMRS. by the way both groups were treated with the standard treatment of Bipolar Disorder. and the researcher does not know that which patient is receiving Citicolin and which is receiving placebo,and in this research one of psychiatric doctor will randomly choose which 35 patients receive Citicolin and which other 35 patients were to receive placebo treatment.
Participants/Inclusion and exclusion criteria
Young Mania Rating Scale greater than or equal to 20
Consent agreement to participate in the study
Hospital Admission due to psychiatrist opinion
Age greater than or equal to 16
Intervention groups
35 patient diagnosed with Bipolar Disorder in manic phase treated with one dose of 250 mg/kg of Citicolin for 2 weeks and 35 patients in the control group that were receiving placebo.
Main outcome variables
Young Mania Rating Scale is measured at admission,1 and 2 weeks after intervention in mania phase of Bipolar Disorder patients and mood changes in the 2 groups receiving Citicolin and placebo are examined
General information
Reason for update
Acronym
Citicolin in Bipolar Disorder
IRCT registration information
IRCT registration number:IRCT20090304001743N17
Registration date:2020-08-02, 1399/05/12
Registration timing:prospective
Last update:2020-08-02, 1399/05/12
Update count:0
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Additive effect of Citicoline on conventional treatment of Bipolar in curent manic episode
Public title
Effect of Citicoline in Bipolar Disorder in current manic epiode
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Young Mania Rating Scale greater than or equal to 20
Consent agreement to participate in the study
Hospital Admission due to psychiatrist opinion
Age greater than or equal to 16
Exclusion criteria:
Psychiatric disorders except Bipolar 1 Disorder
Not to have medical disease
Citicolin Contraindication
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
we use random blocks of 4 ,utilizing 4 sheets of paper. then , we write number "1 " on 2 sheets and number" 2" on two other sheets.in this context ,"1 "means intervention and " 2 " means comparison, we combine those sheets and place them in the table drawer .each time the patient pulls out one of the sheets randomly , according as which numbler 1 or two is pulled out ,it wil be assigned to intervention group or comparison group.Also it is wise to say that the sheets that are pulled out ,will not be returned to the drawer until all the 4 sheets have been pulled out ,so after pulling out the last sheet all the sheets will be returned to the drawer and this process will be done for the next four patients until we get to the number of samples needed ,And in this researcher the drug and placebo are not notified by the researcher and the patient, So the study will be done double blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, placebo, which is precisely in the form of a drug product, is administered randomly to the patients and explained to the patients that he or she may receive a drug or placebo. Therefore, the patient and the clinical caregiver are not aware of the type of product.The other person other than the investigator is responsible for the preparation of the drug and placebo boxes and the researcher is not aware of it. The investigator of the outcome is also unaware of the type of product.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
ِFahmideh Bulvar.Mahdieh street
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.UMSHA.REC.1399.148
Health conditions studied
1
Description of health condition studied
Bipolar Disorder manic episode
ICD-10 code
F31.2
ICD-10 code description
Bipolar Disorder, current episode manic severe with psychotic features
Primary outcomes
1
Description
The effectiveness of Citicoline on reduction of mania episode in bipolar patients administered by YMRS
Timepoint
Assessment of mania status administered by Young Mania Rating Scale at the first date of hospitalization, and the first and second week of receiving Citicoline
Method of measurement
Young Mania Rating Scale
Secondary outcomes
1
Description
The reduction of mania symptoms
Timepoint
At the start of the study and the first and second week after receiving citicolin
Method of measurement
Young Mania Rating Scale (YMRS)
Intervention groups
1
Description
Intervention group: 35 patients diagnosed with Bipolar Disorder in manic phase will be treated with 250 mg /day of Citicolin wich will be one dose through inter muscular injection . The Young Mania Rating Scale will be filled for the patients at admission,first and second weeks of treatment.The drug Citicolin stimulates the biosynthesis of phospholipids and the decreaseof inflammtion stables the cell member.The Citicolin injection will be prepared from MINOO Pharmaceutical.
Category
Treatment - Drugs
2
Description
Control group: 35 patients diagnosed with Bipolar Disorder in mania phase will receive placebo besides their standard drug treatment, and the Young Mania Rating Scale will be filled for the patients at admission,first and second weeks of treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Sara Rezaee
Street address
Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Fax
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
2
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Sara Rezaee
Street address
Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Fax
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3838 1646
Fax
+98 81 3838 1646
Email
s-bashirian@umsha.ac.ir
Grant name
Hamedan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sara Rezaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dibaj streethamadan
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Fax
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Rezaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Fax
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sara Rezaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Fax
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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