fluoxetine AND Multiple sclerosis

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2014
INTERVENTION: Intervention 1: oral flouxetine 20 mg for 24 weeks will be given to patient whom randomised to intervention group. Intervention 2: patients whom randomized to placebo group will received placebo capsules during 24 weeks of clinical trial course. oral flouxetine 20 mg for 24 weeks will be given to patient whom randomised to intervention group patients whom randomized to placebo group will received placebo capsules during 24 weeks of clinical trial course Treatment ‐ Drugs CONDITION: Demyelinating diseases of the central nervous system Multiple Sclerosis. ; Demyelinating diseases of the central nervous system PRIMARY OUTCOME: Depression. Timepoint: week 0 and 24. Method of measurement: BDI(BECK depression inventory). Fatigue. Timepoint: week 0 and 24. Method of measurement: FSS(fatigue severity scale) test. Sleep quality. Timepoint: week 0 and 24. Method of measurement: PSQI test. SECONDARY OUTCOME: Clinical status. Timepoint: week 0 and 24. Method of measurement: EDSS (Expanded Disability Status Scale). 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 an
Epistemonikos ID: 23adce1312a6699a2b4d1cd9ceb0799eadfceb1a
First added on: Mar 31, 2022