Effect of fluoxetine on functional recovery of patients with cerebrovascular accident following middle cerebral artery trunk obstruction: a randomized clinical trial
The aim of this study is to evaluate the effect of fluoxetine on functional recovery of patients with ischemic stroke. The present study is a double blind randomized clinical trial. Patients with ischemic stroke due to occlusion of middle cerebral artery trunk will be enrolled base on inclusion criteria. Written informed consent will be obtained from all patients or their families before their inclusion in the study. Participates will be assigned into two groups randomly, using random block, receiving 15 mg fluoxetine or placebo for the first month starting 24 hours after the onset of stroke and then 20 mg for the next two months. Patient will be excluded if any adverse effect happens due to medication. Functional recovery of patients will be evaluated by National Institute of Health Stroke Scale Criteria (NIHSS) and the Beck Depression Inventory (BDI) at the time of admission, date of discharge and 1 month and 3 months and also Modified Rankin Scale (MRS) and Barthel Index (BI) in discharge, 1 month and 3 months after drug administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112228490N1
Registration date:2012-01-25, 1390/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-01-25, 1390/11/05
Registrant information
Name
Seyed Mohammad Seyed Saadat
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983221572-00983223856
Email address
sm_seyedsaadat@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan university of medical sciences
Expected recruitment start date
2012-04-05, 1391/01/17
Expected recruitment end date
2013-04-05, 1392/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fluoxetine on functional recovery of patients with cerebrovascular accident following middle cerebral artery trunk obstruction: a randomized clinical trial
Public title
Effect of fluoxetine on the functional recovery of patients with cerebrovascular accident
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent; unilateral occlusion of middle cerebral artery trunk; resident in Rasht; Admission NIHSS< 20; No history of alcohol abuse; No history of insomnia, epilepsy; No previous history of cerebral hemorrhage and heart of cerebral stroke; No previous history of systemic diseases of other organs, including liver failure and kidney; Absence of cardiac pace maker, severe neuropathy, systemic vascular disease or major affective disorders; Absence of concomitant stroke in an area other than the stroke of the middle cerebral artery. Exclusion criteria: Dissatisfaction of patient during the study; Occurrence of serious adverse drug affects at any time during drug administration; Alcohol abuse during the study period; Occurrence of Post Stroke Depression (PSD) concomitant use of the mono amine oxidase inhibitors or serotonergic drugs such as tricyclic antidepressants and SSRI.
Age
From 55 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Guilan university of medical sciences
Street address
across Alzahra hospital, Namjoo street, Siadati street
City
Rasht
Postal code
4144665385
Approval date
2012-01-11, 1390/10/21
Ethics committee reference number
1901130503
Health conditions studied
1
Description of health condition studied
Cerebral ischemic stroke
ICD-10 code
I63.3
ICD-10 code description
Cerebral infarction due to thrombosis of cerebral arteries
Primary outcomes
1
Description
Disability
Timepoint
On admission day, on discharge day, 1 and 3 month later
Method of measurement
modified Rankin Scale (mRS)
2
Description
Performance in basic Activities of Daily Living
Timepoint
On admission day, on discharge day, 1 and 3 month later
Method of measurement
Barthel Index
3
Description
Functional recovery
Timepoint
On admission day, on discharge day, 1 and 3 month later
Method of measurement
National Institutes of Health Stroke Scale (NIHSS)
4
Description
Depression
Timepoint
On admission day, on discharge day, 1 and 3 month later
Method of measurement
Beck Depression Inventory (BDI) questionnaire
Secondary outcomes
1
Description
cerebral blood flow changes of middle cerebral artery
Timepoint
On admission day, on discharge day
Method of measurement
Transcranial Doppler (TCD)
Intervention groups
1
Description
Fluoxetine, 15 milligram oral pill for the first month and 20 milligram for the next two months in control group
Category
Treatment - Drugs
2
Description
Placebo, 15 milligram oral pill for the first month and 20 milligram for the next two months in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital, Guilan University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Roudbary, Neurologist, Assistant professor
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice chancellor for research and technology
Full name of responsible person
Dr Abdolrasool Sobhani
Street address
Across Alzahra hospitalt, Siadati street, Namjoo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice chancellor for research and technology
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
Guilan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Seyed Saadat
Position
Medical Student
Other areas of specialty/work
Street address
Research vice-chancellorship Building, Mellat St., Namjoo Ave.
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
sm_seyedsaadat@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Poorsina hospital, Guilan Uuniversity of Medical Sciences
Full name of responsible person
Dr Babak Bakhshayesh Eghbali
Position
Assistant professor, Neurologist
Other areas of specialty/work
Street address
Poorsina Hospital
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
bakhshayesh@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Seyed Saadat
Position
Medical Student
Other areas of specialty/work
Street address
Research vice-chancellorship Building, Mellat St., Namjoo Ave.
City
Rasht
Postal code
Phone
Fax
sm_seyedsaadat@gums.ac.ir
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)