progressive multiple sclerosis slow degradation of the insulating layer of the nerve fibers
Conditions
Interventions
fluoxetine
placebo
Sponsors
Prof. dr. J. de Keyser, Neurologie, UZ Brussel
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent. 2.Either secondary or primary progressive MS according to the 2005 Revised McDonald criteria. 3.Age 25-65 years. 4.EDSS at baseline of 3 - 6.5 points inclusive. Disability increased in the preceding year because of steady disease progression unrelated to relapses for at least 12 months. 5.Ability to be compliant with the schedule of protocol assessments. 6.For sexually active female patients with reproductive potential, use of reliable means of contraception.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation 2.Allergy to fluoxetine 3.Use of fluoxetine 4.Use of other antidepressants, unless they can be stopped for 2 months before starting with the study medication. 5.Contraindication for MRI (relative exclusion criterion because patients who have a contraindication are allowed to participate). 6.Major depression following the DSM-IV 7.Other neurologic, serious psychiatric or systemic disorders that could interfere with the assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9-HPT) | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI: diffusion tensor imaging, global brain atrophy and T2 lesion load. Cognition: MACFIMS, BDI, MFIS, HAI Ambulation: Ambulation Index | — |
Countries
Netherlands
Outcome results
None listed