Effect of Fluoxetine on Motor Improvement in Ischemic Stroke Patients: A Double Blind Clinical Trial Study

Background Ischemic stroke is one of the most frequent reasons of adult disability. Newly, few trials have represented that fluoxetine might meliorate functional recovery after stroke. Objectives Our purpose of this study was the evaluation of effectiveness of fluoxetine in rehabilitation of patients after stroke. Methods In this double-blind trial study, patients who admitted for stroke, participated in a double-blind, randomized, clinical trial study with fluoxetine (20 mg once per day, orally), and placebo. They were examined for alterations in a depressive mood, evaluated by the Hamilton depression rating scale (HDRS) and changes in motor impairment, assessed by the Barthel index (BI). assessments of patients were done in days 0, 45 and 90 with BI and HDRS scales according to their functional treatment response. Statistical analyses were performed using the SPSS-16 software. Results One hundred seventy two patients were randomly assigned to fluoxetine (n = 86) or placebo (n = 86), and 150 were included in the analysis (75 in the fluoxetine group and 75 in the placebo group). BI improvement at day 90 was significantly greater in fluoxetine group (3.09 ± 1.57 points, P < 0.001) than in the placebo group (1.70 ± 1.33, P < 0.001). Based on improvement in both HDRS and BI scores we separated patients into two poor and good prognosis groups. A good prognosis group comprised 55 patients (73.3%) treated with fluoxetine and 17 patients (22.7%) treated with placebo. Conclusions Early prescription of fluoxetine has significant effect on motor improvement after ischemic stroke.