The aim of this double blind randomized clinical trial is to assess efficacy of Citalopram on ischemic stroke patient's functional outcome (at least 50% improvement in the 3-month NIHSS compared to the baseline score ) compared with placebo. Inclusion criterion for this research is having ischemic stroke; no previous use of citalopram and other antidepressants or neuroleptic drugs, in the last month before the onset of symptoms; not having a severe disability after stroke and depression. Exclusion criteria are as: Previous chronic disease interferes with the performance evaluation in patients; Residual weakness from previous stroke; Thrombolytic therapy; Endarterectomy and Depression. 144 patients referring to Razi university hospital diagnosed as ischemic stroke will be randomly allocated to receive either Citalopram (20mg/Daily) or placebo. The main outcome of the trial is the effect of drug on functional status after ischemic stroke. The primary outcome of this study is functional status after stroke measured through.(National Institutes of Health Stroke Scale(NIHSS) and modified Rankin scale (mRS) three times (At hospitalization, discharge and after 3 months).
General information
Acronym
COISO
IRCT registration information
IRCT registration number:IRCT201203192150N2
Registration date:2012-04-22, 1391/02/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-22, 1391/02/03
Registrant information
Name
Homayoun Sadeghi Bazargani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3741
Email address
homayoun.sadeghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurosciences Research center of Tabriz University of medical sciences.
Expected recruitment start date
2012-05-10, 1391/02/21
Expected recruitment end date
2012-10-10, 1391/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Citalopram on Three Months Functional Prognosis of Acute Ischemic Stroke Patients: A Randomized Clinical Trial
Public title
Effect of Citalopram on Three Months Functional Prognosis of Acute Ischemic Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Acute ischemic stroke hospitalization in Razi university hospital; 2- No previous use of citalopram and other antidepressants, MAOI, Neuroleptic drugs and benzodiazepines in the last month before the onset of symptoms; 3- Not having a severe disability after stroke(NIHSS<20); 4-Not having Depression(MADRS>18). Exclusion criteria: 1- Request of patients to Exit from the study; 2- Previous chronic disease interferes with the performance evaluation in patients such as: chronic infections, liver or kidney failure, cancers; 3- Residual weakness of previous stroke; 4- Pregnancy or breastfeeding or any conditions that makes follow up impossible; 5- Sever loss of Consciousness; 6- Thrombolytic therapy; 7-Endarterectomy; 8- Depression(MADRS>18).
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Daneshgah street , Deputy for research, Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
9094
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Functional status after stroke
Timepoint
At hospitalization(0), discharge(1), and after 3 months(2)
Method of measurement
Functional status score based on NIHSS(National institutes of health stroke scale)(at least 50% reduction in NIHSS score in 3-month compared to the baseline score
Secondary outcomes
1
Description
Prognosis after stroke
Timepoint
At hospitalization(0), discharge(1), and after 3 months(2)
Method of measurement
Modifi ed Rankin scale (MRS)
Intervention groups
1
Description
Citalopram tablets(produced with commercial name as Citalopram product by Sobhan Pharma Co.)/ 20 mg Daily
Category
Treatment - Drugs
2
Description
Placebo as the same shape and size and color as Citalopram tablets
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University hospoital
Full name of responsible person
Dr. Savadi oskoei
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neurosciences Research Center
Full name of responsible person
Dr.Farhoudi
Street address
Golgasht street, Imam Reza Hospital, Neurosciences Research Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurosciences Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ehsan Sharifipour
Position
MD, Resident of Neurology specialty degree
Other areas of specialty/work
Street address
Neurology department, Razi university hospital, Elgoli ave
City
Tabriz
Postal code
Phone
+98 41 1442 8346
Fax
Email
sharifipour.e@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Daryoush Savadioskouei
Position
Neurologist and Associate Professor of Neurology Department of Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Neurology department, Razi university hospital, Elgoli ave
City
Tabriz
Postal code
Phone
+98 41 1336 4672
Fax
Email
d.savadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Position
MD, Resident of Neurology specialty degree
Other areas of specialty/work
Street address
Neurology Department, Razi university hospital, Elgoli ave
City
Tabriz
Postal code
Phone
+98 41 1442 8346
Fax
Email
sharifipour.e@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)