This study accomplishes on the patients with motor deficit from stroke that are addmitted in Emam Reza hospital. Patients divide to two groups accidentally, group A : case (that take fluoxetin) and group B: control(that take placebo).Befor use of drug,we fill a motor scale (Barthe Index(BI)) anda psychiatric index(Hamilthon Depression Rating Scale(HDRS)) for each patient.whole time of treatment is 90 days and during this period patients is treated with 30 course of physiotherapy during addmission and after discharge . In day 45 and 90 patients reexamine and the noted scales(BI and HDRS) will fill for them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312088323N7
Registration date:2014-01-09, 1392/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-09, 1392/10/19
Registrant information
Name
Nazanin Razazian
Name of organization / entity
Neurology Department of Kermanshah Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 3409
Email address
nrazazian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Survey for Assessment of Effectiveness of Fluoxetine on Motor Improvement in Ischemic Stroke Patients
Public title
A Survey for Assessment of Effectiveness of Fluoxetine on Motor Improvement in Ischemic Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: stroke in middle cerebral artery( documented with imaging) and the patient have a hemi or mono plegy or paresis؛the patient was not comatose ؛ filling the agreemnet sheet with patient or a reliable attendant ؛ the patient is dischargable and not admitted in ICU ward
exclusion criteria: death of patient with any cause in duration of study ؛ irregular use of drugs ؛ irregular return for reexaminations ؛ presence of seizure, severe diarrhea, vomiting, severe insomnia ؛ presence of metabolic disorder( hyperthyroidism, hepatic , renal, cardiac,...) ؛ past medical history of psychiatric disorder or severe depression before stroke ؛ presence of SAH, lobar ICH, brain tumor ؛ stroke in other vascular territories (MCA, ACA,...) ؛ simmultaneous use of MAO-i , Selegiline, Cyproheptadine.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science
Street address
Shahid beheshti boulvered- building no.2 - reserch adjutancy
City
Kermanshah
Postal code
-
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
34739
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.0
ICD-10 code description
Middle cerebral artery syndrome
Primary outcomes
1
Description
motor deficit and psychiatric disorder
Timepoint
before study,day 45, day 90
Method of measurement
Hamilthon depression rating Scale(HDRS) for psychiatric disorders and Barthel Index( BI ) for motor assessment.
Secondary outcomes
empty
Intervention groups
1
Description
In case group we prescribed cap fluoxetin,20 mg, P.O. one time a day for 90 days.
Category
Treatment - Drugs
2
Description
In control group we prescribe a capsule with same size and color to fluoxetin ,(as placebo) for 90 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah- Emam reza hospital
Full name of responsible person
Omid Esmaeili M.D.
Street address
Emam Reza hospital
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Mr. Shirzadian
Street address
Shahid Beheshti boulvered- building no.2 -research center
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Science
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
Kermanshah University of Medical Science
Full name of responsible person
Omid Esmaeili M.D.
Position
resident of neurology
Other areas of specialty/work
Street address
Kermanshah-Emam Reza hospital
City
Kermanshah
Postal code
-
Phone
+98 83142763009
Fax
-
Email
dr_omid_esmaeili@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Nazanin Rzazian M.D.
Position
Assistant Professor
Other areas of specialty/work
Street address
Kermanshah- Emam Reza hospital- Neurology department
City
Kermanshah
Postal code
-
Phone
+98 83142763009
Fax
-
Email
nrazazian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Omid Esmaeili M.D.
Position
Resident of Neurology
Other areas of specialty/work
Street address
Kermanshah- Emam Reza hospital_ Neurology department
City
Kermanshah
Postal code
-
Phone
+98 83142763009
Fax
-
Email
dr_omid_esmaeili@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)