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

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

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 Criteria

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 (SSRI's)
6. Treatment with Monoamine Oxidase (MAO)-inhibitors, oral anticoagulantia, 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients with progression in two years. Progression is defined as:<br>1. Persistent (two or more follow-up assessments) worsening of EDSS with 1.0 point with basis EDSS 3.0 to 5.0 or persistent (two or more follow-up assessments) worsening of EDSS with 0.5 with basis EDSS 5.5 to 6.5<br>2. Or persistent (two or more follow-up assessments) worsening of 9-Hole Peg Test (9-HPT) with 20% compared to baseline measurement<br>3. Or persistent (two or more follow-up assessments) worsening of the AI of one point with a basis AI between two and six

Secondary Outcome Measures

Name	Time	Method
1. Change in the following MRI measurements:<br>a. T2 lesion volume<br>b. T1 lesion volume (black holes)<br>c. Brain atrophy<br>d. N-Acetyl Aspartate (NAA)<br>e. Apparent Diffusion Co-efficient (ADC) and Fractional<br>Anisotropy (FA) histogram values<br>2. Change in EDSS, MSFC, SF-36, Guys Neurological Disability Scale, BDI, Family Intrusiveness Scale (FIS)<br>3. Time (in months) to progression