Effects of fluoxetine on functional outcomes after acute stroke

Researchers in the United Kingdom conducted the Fluoxetine Or Control Under Supervision (FOCUS) trial to examine if stroke patients would have improved functional outcomes with a 6-month course of fluoxetine compared with placebo. The trial, conducted at 103 U.K.

Researchers in the United Kingdom conducted the Fluoxetine Or Control Under Supervision (FOCUS) trial to examine if stroke patients would have improved functional outcomes with a 6-month course of fluoxetine compared with placebo. The trial, conducted at 103 U.K. hospitals, involved more than 3,100 adults with a clinical diagnosis of acute stroke with brain imaging compatible with intracerebral hemorrhage or ischemic stroke and had focal neurological deficits. Participants received oral fluoxetine 20 mg or placebo once daily for 6 months. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at the 6-month follow-up. The researchers used the simplified mRS questionnaire delivered by mail, supplemented by a telephone interview if necessary. The results of the trial indicate that fluoxetine 20 mg given daily for 6 months after an acute stroke did not significantly enhance patients' functional outcome or survival at 6 and 12 months. Researchers also found that the drug reduced the occurrence of depression but increased the risk for bone fractures at 6 months. More research needs to be conducted to determine additional benefits or harms, the authors concluded.