Recent studies have indicated that fluoxetine could accelerate the neurological recovery after stroke. This study aims to investigate the safety and efficacy of fluoxetine in improving functional outcome after acute stroke.

This is an investigator-led, multicenter, multicenter, double-blind, randomized, placebo-controlled study that included 1,500 participants aged 18 years or older. The eligible participants had a clinical diagnosis of intracerebral or ischaemic hemorrhage and at least one persistent focal neurological deficit. The participants were randomly divided into two equal groups; 750 were assigned to 20 mg fluoxetine per day and 750 to placebo for six months. The primary outcome was functional status measured with the modified Rankin Scale (mRS). 

At six months of follow-up, 737 patients of the fluoxetine group and 742 patients of the placebo group were available. There was no effect of fluoxetine on distribution across mRS scored. The patients diagnosed with depression were lesser with fluoxetine than placebo. However, fluoxetine was associated with more bone fractures and a higher incidence of hyponatremia.

The research concluded that fluoxetine treatment was not associated with an improved functional outcome after stroke. Fluoxetine alleviated the occurrence of depression, but it also increased the risk of bone fractures and hyponatremia.