The aim of the present study was to determine the anti-inflammatory effects of fluoxetine on fatigue in patients with relapsing MS and also to survey the changes in sleep quality and depression
In a triple-blind, placebo-controlled exploratory study, 60 non-depressed patients with relapsing remitting MS were randomized to oral fluoxetine 20 mg or placebo daily for 24 weeks. fatigue, sleep quality and depression evaluation performed on weeks 1 and 24 by assessing FSS(Fatigue Severity Scale), PSQI(Pittsburgh Sleep Quality Index) and BDI(Beck Depression Inventory).Clinical activity of MS was also studied by assessing EDSS (Expanded Disability Status Scale)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062017811N3
Registration date:2014-06-22, 1393/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Shayan Amjadi
Name of organization / entity
Students Research Committee,Arak Universiry of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.amjadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Office of Vice Chancellor for Research
Expected recruitment start date
2013-07-02, 1392/04/11
Expected recruitment end date
2014-06-01, 1393/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fluxetine on Fatigue,sleep quality and depression in Patients with Multiple Sclerosis
Public title
fluoxetine AND Multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18–50 years؛ پclinically definitive relapsing remitting MS((according to the 2005 revised McDonald criteria)confirmed by a neurologist ؛ Additional inclusion criteria were an Expanded disability Status Score (EDSS) of less or equal to 5.5 ؛ exclusion criteria: progressive forms of multiple sclerosis ؛ an onset of relapse or receipt of any glucocorticoid treatment during trial period ؛ use of immunomodulatory, immunosuppressive, IVIg or plasmapherasis or antidepressant drugs in the previous 6 months؛ the use of corticosteroids in the previous 8 weeks ؛ depression defined as a score of 19 or higher on Beck’s Depression Inventory II ؛contraindication to MRI ؛ other neurological or systemic disorder that would interfere with the assessments ؛ pregnancy or unwillingness to use acceptable birth control. severe suicidality including ideation, plan, and intentclinically significant ؛ unstable medical or surgical conditions that would preclude safe and complete participation in the study.
Age
From 18 years old to 50 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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of medical science
Street address
Arak University of medical science,sardasht,arak,iran
City
Arak
Postal code
Approval date
2013-02-02, 1391/11/14
Ethics committee reference number
92-143-10
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
fatigue
Timepoint
week 0 and 24
Method of measurement
FSS(fatigue severity scale) test
2
Description
sleep quality
Timepoint
week 0 and 24
Method of measurement
PSQI test
3
Description
depression
Timepoint
week 0 and 24
Method of measurement
BDI(BECK depression inventory)
Secondary outcomes
1
Description
Clinical status
Timepoint
week 0 and 24
Method of measurement
EDSS (Expanded Disability Status Scale)
Intervention groups
1
Description
oral flouxetine 20 mg for 24 weeks will be given to patient whom randomised to intervention group
Category
Treatment - Drugs
2
Description
patients whom randomized to placebo group will received placebo capsules during 24 weeks of clinical trial course
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of valiasr hospital-Arak MS society-private offices
Full name of responsible person
Dr.Fardin Faraji
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science,Office of Vice Chancellor for Research
Full name of responsible person
Davoud Hekmatpo
Street address
Arak univercity of medical science , Arak , Iran
City
Arak
Grant name
22100000 ریال
Grant code / Reference number
907
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science,Office of Vice Chancellor for 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
Students Research Committe , Medicine faculty , Aarak University of Medical Science
Full name of responsible person
Shayan Amjadi
Position
Medical student
Other areas of specialty/work
Street address
Arak University of Medical Science , Sardasht , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
sh.amjadi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurology Department , Medicine faculty, Arak university of medical science
Full name of responsible person
Fardin Faraji
Position
Neurology specialist,Associate Professor,
Other areas of specialty/work
Street address
Arak University Of Medical Science,Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
faraji@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Students Research Committee , Arak University of Medical Science
Full name of responsible person
Shayan Amjadi
Position
Medical student
Other areas of specialty/work
Street address
Aak University of Medical Science , Arak , Iran
City
Arak
Postal code
Phone
+98 86 3417 3502
Fax
Email
sh.amjadi@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)