IRCT2014052417811N2
Completed
Phase 3
The Effect of Fluxetine on Disease Clinical & Radiologic activity of Multiple sclerosis
Arak University of Medical Science,Office of Vice Chancellor for Research0 sites58 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- multiple sclerosis.
- Sponsor
- Arak University of Medical Science,Office of Vice Chancellor for Research
- Enrollment
- 58
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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