Fluxetine AND Multiple Sclerosis
- Conditions
- multiple sclerosis.Demyelinating diseases of the central nervous system
- Registration Number
- IRCT2014052417811N2
- Lead Sponsor
- Arak University of Medical Science,Office of Vice Chancellor for Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 58
inclusion criteria: age 18–50 years? ?clinically 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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EDSS (Expanded Disability Status Scale). Timepoint: WEEK 0 AND24. Method of measurement: evaluate by neurologist.;The cumulative number of lesions on different phases of brain MRI. Timepoint: WEEK 0 AND24. Method of measurement: counting the plaques by researchers.
- Secondary Outcome Measures
Name Time Method