Fluoxetine in progressive multiple sclerosis: a placebo-controlled randomised trial

Treatment tested

• Fluoxetine

Other measures (1)

Inclusion: 1. Written informed consent 2. Age 18 to 65 3. MS according to the McDonald criteria or primary progressive MS according to the Thompson criteria 4. Expanded Disability Status Scale (EDSS) 3.0 to 6.5 inclusive 5. Documented progression in the last two years unrelated to clinical exacerbations in the last two years Exclusion: 1. Contra-indication Magnetic Resonance Imaging (MRI) (e.g., metal, claustrophobia) 2. Women of childbearing potential, who are not using a medically accepted safe method of contraception 3. Pregnancy or women who are lactating 4. Moderate to severe depression measured as a score of more than 18 on the Beck Depression Inventory (BDI) 5. Treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) 6. Treatment with Monoamine Oxidase (MAO)-inhibitors, oral anticoagulants, Serotonin (5-HT) agonists and/or lithium 7. Treatment with interferon ß, glatiramer acetate, plasmapheresis, natalizumab, other immunomodulatory drugs, or immunosuppressive drugs including azathioprine, cyclophosphamide and methotrexate, within six months of week zero 8. Treatment with corticosteroids within three months of week zero 9. Renal failure 10. Neurological disorder other than MS, acute or chronic infection, malignant neoplasm or metastasis, cardiovascular disorder or pulmonary disorder, severe intercurrent systemic disease, or any other disease that interferes with the assessments

Not provided at time of registration