Background: Fluoxetine may improve the poststroke emotional disturbances. The purpose of the present study was to evaluate the efficacy of fluoxetine on quality of life (QOL) over time in stroke patients with emotional disturbances. Methods: We studied 152 consecutive stroke patients (mean age, 58 years) who had either poststroke depression (PSD), emotional incontinence (PSEI) or anger proneness (PSAP) at an average of 14 months (range = 3–28) after the onset of stroke. The Korean version of SF-36 was used to assess the QOL. The presence of PSD, PSEI and PSAP was also determined with a standardized questionnaire. The subjects were given either 20 mg/day of fluoxetine (n = 76) or placebo (n = 76) for 3 months. Follow-up evaluations were done at 3, 6 and 12 months after the beginning of the treatment. Results: The score in the mental health domain was significantly higher in the fluoxetine group than in the placebo group at the 3-, 6- and 12-month follow-ups. The scores in the general health (p < 0.05) and social functioning (p < 0.05) domains were also significantly higher in the fluoxetine than in the placebo group at 12 months of follow up even if there was no definitive improvement in PSD, PSEI and PSAP at this time. Conclusions: Fluoxetine is effective in improving QOL, particularly so in the mental health subdomain. Our results suggest that fluoxetine may be used to improve the QOL of stroke patients with emotional disturbances.

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