Evaluation of preventive effects of sertraline in reducing physical and mental disabilities of patients with stroke of brain and increasing their therapeutic alliance and quality of life. 80 patients admitted to neurology ward of Razi university hospital during 2012-2013 will be enrolled in this study and will be randomly assigned to two groups receiving either sertraline or placebo. patients from both gender aged between 55 and 75 which are experiencing stoke for the first time will be enrolled. Patients with renal, hepatic or cardiac failure and patients with substance related disorders will be excluded.
The two groups will be monitored every 3 months regarding recurrent stroke, therapeutic alliance, procedure of the therapy and degree of disability for 9 months according to the questionnaires of Quality of life and Beck Depression Inventory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101011062N1
Registration date:2012-11-28, 1391/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
Reza Pirzeh
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 3353
Email address
pirzehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-10, 1391/06/20
Expected recruitment end date
2012-12-10, 1391/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of sertraline effect on quality of life in stroke inpatients
Public title
sertraline effect on stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: inpatients which are experiencing stroke for the first time will be enrolled.Exclusion criteria: past history of stroke ;renal failure; hepatic failure; cardiac failure; substance related disorders
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 (TUOMS)
Street address
Univesity Main Street, Tabriz, Iran tel :3355921
City
tabriz
Postal code
5165687386
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
9091
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Quality of life
Timepoint
3 months, 6 months, 9 months
Method of measurement
Nottingham Health Profile
Secondary outcomes
1
Description
Depression
Timepoint
3 months, 6 months, 9 months
Method of measurement
Beck depression inventory
Intervention groups
1
Description
Intervention:3 weeks after stroke each patient in this group reseived Sertraline 50 mg per day for 12 months.
Category
Treatment - Drugs
2
Description
control: 3 weeks after stroke each patient in this group reseived a placebo tablet every day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Reza Pirzeh
Street address
Psychiatry department, Razi Hospital, El Goli Road, tabriz,East AZerbaijan, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical sciences, Vice chancellor of research
Full name of responsible person
Ali Meshkini M.D
Street address
Dean of Research, Faculty of Medicine, Tabriz University of Medical Sciences, Univesity Main Street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of medical sciences, Vice chancellor of research
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
Department of Psychiatry
Full name of responsible person
Reza Pirzeh
Position
Resident in psychiatry
Other areas of specialty/work
Street address
Elgoli road
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 3353
Fax
Email
pirzehr@tbzmed.ac.ir rezapirzeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Univeristy of medical sciences
Full name of responsible person
Mohammad Ali Ghoreishizadeh
Position
Professor
Other areas of specialty/work
Street address
Razi Hospital, Elgoli road
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 3353
Fax
Email
goreshim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Raze Pirzeh
Position
Resident in psychiatry
Other areas of specialty/work
Street address
Department of psychiatry, Razi Hospital, Elgoli road, Tabriz, Iran
City
Tabriz
Postal code
5167846184
Phone
+98 41 1380 3353
Fax
+98 41 1380 3353
Email
pirzehr@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)