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

Recruiting

Conditions: multiple sclerosis

Registration Number: NL-OMON23448

Lead Sponsor: Multiple Sclerosis Internationaal

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

1. 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 Criteria

1. 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 ß, 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.

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 (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;<br>2. Or persistent (2 or more follow-up assessements) worsening of 9-HPT with 20% compared to baseline measurement;<br>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 Outcome Measures

Name	Time	Method
1. Change in the folowing MRI measurements:<br>a. T2 lesion volume;<br>b. T1 lesion volume (black holes);<br>c. Brain atrophy;<br>d. NAA;<br>e. ADC and FA histogram values;<br>2. Change in EDSS, MSFC, SF-36, Guys Neurological Disability Scale, BDI, FIS;<br>3. Time (in months) to progression.