Fluoxetine is not effective in the treatment of post-stroke fatigue: a double-blind, placebo-controlled study

Although post-stroke fatigue (PoSF) is common, pharmacological interventions to improve PoSF have rarely been carried out. The purpose of the present study was to evaluate the therapeutic effect of fluoxetine on PoSF.

We studied 83 consecutive outpatients with PoSF at an average of 14 months after the onset of stroke. The presence of post-stroke depression, post-stroke emotional incontinence and post-stroke anger proneness was also evaluated with the use of a standardized questionnaire. The presence of PoSF and pre-stroke fatigue was assessed. The visual analogue scale (VAS) and Fatigue Severity Score (FSS) were used to assess PoSF. The subjects were given either 20 mg/day of fluoxetine (n = 40) or placebo (n = 43) for 3 months. Follow-up evaluations were done 3 and 6 months after the beginning of the treatment.

The initial mean fatigue VAS score and the mean overall FSS score were 5.4 +/- 2.0 and 4.4 +/- 1.2, respectively. There were no differences in the number of patients with PoSF between the fluoxetine group and the placebo group at 3 and 6 months after the treatment. The percent changes in VAS scores and FSS at all follow-up assessments were not significantly different either. However, fluoxetine significantly improved post-stroke emotional incontinence (p < 0.05) and post-stroke depression (p = 0.05) in the patients with PoSF.

Fluoxetine does not improve PoSF, although some concomitant emotional disturbances improved significantly. Our results suggest that PoSF may be associated with diverse etiologies but not closely related to serotonergic dysfunction. Further studies are required to elucidate the causative factors and to find an appropriate treatment for PoSF.