Fluoxetine vs placebo for depressive symptoms after stroke: failed randomised controlled trial

Growth in antidepressant prescribing is a well-recognised phenomenon in developed countries. In stroke care, the evidence of effectiveness from systematic reviews is surprisingly weak. We therefore decided to undertake a randomised controlled trial comparing fluoxetine to placebo.

Double blind placebo-controlled trial. Cases were high-scorers on the GHQ-28 and we applied minimal exclusion criteria.

Despite screening 614 patients we were able to randomise only one into the trial. High rates of refusal to participate and exclusions due to physical ill health were coupled with high rates of prescribing among stroke clinicians, to cause this recruitment problem.

In addition to the predicted practical problems of conducting an RCT in an elderly frail population, it became clear that most clinicians are not in equipoise about the value of antidepressant medication despite the lack of strong evidence for its effectiveness.