Abstract
BACKGROUND: Stroke is the primary cause of disability worldwide, the second most common cause of dementia and the third leading cause of death. Only few studies were conducted to study the role of fluoxetine in motor recovery in either ischemic or hemorrhagic stroke patients with probably less severe paresis. However, the current study evaluates both the effectiveness and safety of fluoxetine in the stroke population with a more severe motor deficit. METHODS: Patients who had acute or subacute stroke with hemiparesis and aged between 18 and 80 years with medical research council (MRC) scale score <4 were included in this randomized, Single-blind, placebo-controlled trial in 1:1 ratio to placebo or fluoxetine 20 mg/day orally for 90 days. The primary outcome measures were changes in barthel index, time taken to complete nine hole peg test and number of hand tapping movements in 30 s by the affected limb between baseline, 45th day and 90th day. The secondary outcome measure was evaluation of the drug tolerability. RESULTS: A total of 168 patients were assigned to fluoxetine (n = 84) or placebo (n = 84) group. Mean BI score significantly improved at 90th day in fluoxetine group (70.42 ± 10.56) than in placebo group (44.23 ± 8.52). Mean dexterity value decreased significantly at 90th day (2.61 ± 0.81) compared to baseline (3.98 ± 0.53) in fluoxetine group. However higher rate of decrease of mean dexterity value was seen in fluoxetine group when compared to placebo group. Mean number of hands tapping movements in 30 s increased significantly at 90th day (16.33 ± 3.58) compared to baseline (9.83 ± 2.92) in fluoxetine group. Few ADR reported during this study were dizziness, drowsiness and insomnia. CONCLUSION: The present study indicates that early prescription of fluoxetine is safe and may enhance motor function in patients presenting with severe motor impairments after stroke. However, the findings of the study should be confirmed in future controlled studies with large sample size.