Table of Contents
ISRN Neurology
Volume 2013, Article ID 370943, 6 pages
Clinical Study

The Effect of Fluoxetine on Progression in Progressive Multiple Sclerosis: A Double-Blind, Randomized, Placebo-Controlled Trial

1Department of Neurology, University Medical Center Groningen, University of Groningen, Postbus 30.001, 9700 RB Groningen, The Netherlands
2Department of Neurology, Rijnstate Hospital, Postbus 9555, 6800 TA Arnhem, The Netherlands
3Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
4Department of Neurology, Center for Neurosciences, University Hospital Brussels, Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium

Received 19 March 2013; Accepted 16 April 2013

Academic Editors: D. E. Bulman, C.-M. Chen, G. Meco, and D. Schiffer

Copyright © 2013 Jop Mostert et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Preclinical studies suggest that fluoxetine may have neuroprotective properties. In this pilot study forty-two patients with secondary or primary progressive MS were randomized to receive fluoxetine 20 mg twice daily or placebo for 2 years. Every 3 months the Expanded Disability Status Scale (EDSS), 9-hole peg test (9-HPT) and ambulation index (AI) were assessed. Brain MRI scans, Multiple Sclerosis Functional Composite, Fatigue Impact Scale, Guy’s neurological disability Scale and SF-36 were performed at baseline, year 1 and year 2. Seven out of 20 (35%) patients in the fluoxetine group and 7 out of 22 (32%) patients in the placebo group had sustained progression on the EDSS, 9-HPT, or AI at 2 years. No differences were identified between the 2 treatment groups with respect to secondary clinical outcomes and T2 lesion load, grey matter volume and white matter volume. An unanticipated low rate of disability progression in the placebo group decreased the statistical power. At least 200 patients would have been needed to detect a 50% treatment effect. This trial shows that fluoxetine was generally well tolerated, but no assumptions can be made about a possible treatment effect. An adequately powered controlled trial of fluoxetine in progressive MS is still warranted. This trial is registered with Current Controlled Trials ISRCTN38456328.