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Fluoxetine in progressive multiple sclerosis: A placebo-controlled randomized trial.


- candidate number2037
- NTR NumberNTR639
- ISRCTNISRCTN38456328
- Date ISRCTN created15-sep-2006
- date ISRCTN requested13-sep-2006
- Date Registered NTR24-mrt-2006
- Secondary IDsN/A 
- Public TitleFluoxetine in progressive multiple sclerosis: A placebo-controlled randomized trial.
- Scientific TitleFluoxetine in progressive multiple sclerosis: A placebo-controlled randomized trial.
- ACRONYMN/A
- hypothesisFluoxetine has in animals and cell cultures neuroprotective properties. We test whether fluoxetine is able to reduce progression in patients with multiple sclerosis.
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS)
- Inclusion criteria1. Written informed consent; 2. Age 18-65; 3. Multiple sclerosis (MS) according to the Mc Donald criteria or primary progressive MS according to the Thompson criteria; 4. EDSS 3.0-6.5 inclusive; 5. Documented progression in the last 2 year unrelated to clinical exacerbations in the last 2 year.
- Exclusion criteria1. Contra-indication MRI (eg. 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 > 18 on the Beck Depression Inventory; 5. Treatment with SSRI's; 6. Treatment with MAO-inhibitors, oral anticoagulantia,5-HT agonists and/or lithium; 7. Treatment with interferon , glatiramer acetate, plasmapheresis, natalizumab, other immunomodulatory drugs, or immunosuppressive drugs including azathioprine, cyclophosphamide and methotrexate, within 6 months of week 0; 8. Treatment with corticosteroids within 3 months of week 0; 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-nov-2008
- Target number of participants42
- Interventions1. Treatment with fluoxetine 40 mg/day or placebo during 2 years; 2. Every 3 months clinical evaluation (EDSS, MSFC, AI); 3. Yearly cerebral MRI; 4. Yearly questionairres (Guys Neurological Disability Scale, BDI, SF-36).
- Primary outcomeNumber of patients with progression in two years. Progression is defined as: 1. Persistent (2 or more follow-up assessements) worsening of EDSS with 1.0 point with basis EDSS 3.0-5.0 or persistent (2 or more follow-up assessements) worsening of EDSS with 0.5 with basis EDSS 5.5-6.5; 2. Or persistent (2 or more follow-up assessements) worsening of 9-HPT with 20% compared to baseline measurement; 3. Or persistent (2 or more follow-up assessements) worsening of the AI of 1 point with a basis AI between 2 and 6.
- Secondary outcome1. Change in the folowing MRI measurements: a. T2 lesion volume; b. T1 lesion volume (black holes); c. Brain atrophy; d. NAA; e. ADC and FA histogram values; 2. Change in EDSS, MSFC, SF-36, Guys Neurological Disability Scale, BDI, FIS; 3. Time (in months) to progression.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J.P. Mostert
- CONTACT for SCIENTIFIC QUERIESDrs. J.P. Mostert
- Sponsor/Initiator University Medical Center Groningen (UMCG), Multiple Sclerosis Internationaal
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds University Medical Center Groningen
- PublicationsN/A
- Brief summaryIn this placebo-controlled randomized trial, we study whether fluoxetine 40 mg/day is able to reduce progression in patients with multiple sclerosis after 2 years of treatment.
- Main changes (audit trail)
- RECORD24-mrt-2006 - 12-jan-2009


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