Almeida OP, Hankey GJ, Ford A, et al. - According to this randomized, double-blind, placebo-controlled clinical trial, when compared with placebo, routine daily treatment with 20 mg of fluoxetine did not reduce the proportion of people experiencing clinically significant symptoms of depression after a stroke, nor did it affect the proportion of people prescribed an antidepressant or receiving nonpharmacologic treatments.

• In total, 607 participants (378 men [62.3%]; mean [SD] age, 64.3 [12.2] years) were randomly assigned treatment with placebo, and 614 participants (397 men [64.7%]; mean [SD] age, 63.4 [12.4] years) were randomly assigned to fluoxetine hydrochloride 20 mg daily treatment.

• For demographic and clinical measures, the groups were balanced.

• PHQ-9 scores of 9 or higher were found in 112 patients (18.5%) in the placebo group and 116 patients (18.9%) in the fluoxetine group at baseline.

• During the follow-up period, 126 of the 596 participants (21.1%) were given a placebo and 121 of the 598 participants (20.2%) given fluoxetine had PHQ-9 scores of 9 or higher.

• During the trial, a similar proportion of participants with PHQ-9 scores less than 9 at baseline who were treated with fluoxetine hydrochloride or placebo developed PHQ-9 scores of 9 or higher.

• A slightly higher proportion of participants in the placebo group than in the fluoxetine group had a participant-reported clinician diagnosis of depression.

• By week 26, 14 people in the placebo group (2.3%) and 12 people in the fluoxetine group (1.9%) had died.