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Uncertainty Raised in Use of Fluoxetine for Poststroke Motor Recovery

Information sourced from NEJM Journal Watch:

Uncertainty Raised in Use of Fluoxetine for Poststroke Motor Recovery

The large randomized, controlled FOCUS trial showed no motor benefit from 6 months of fluoxetine use after stroke.

A previous randomized study (FLAME; NEJM JW Neurol Mar 2011 and Lancet Neurol 2011; 10:123) in patients with ischemic stroke showed that fluoxetine was superior to placebo in terms of motor recovery and functional independence. However, the study was relatively small and short-term (assessing 90-day outcomes), and uncertainty has persisted about the value of selective serotonin reuptake inhibitors (SSRIs) following stroke. The larger Fluoxetine or Control Under Supervision (FOCUS) trial now provides more information on this topic. In FOCUS, 3127 patients (mean age, 71.4 years; 62% men) were recruited and assigned to treatment with either fluoxetine 20 mg or placebo daily for 6 months. Patients had a clinical diagnosis of stroke with focal neurologic deficits and were randomized 2 to 15 days after stroke onset (mean, 7 days). Most patients (90%) had ischemic strokes, and 92% were independent prestroke. The mean NIH stroke scale score was 6 at the time of study entry.

The primary endpoint — distribution of modified Rankin Scale scores (mRS) at 6 months — did not differ between the fluoxetine and placebo groups. Functional independence (mRS score of 0–2) occurred in 36% of fluoxetine recipients and 38% of placebo recipients, a nonsignificant difference. Fluoxetine recipients had a significantly lower rate of new depression than placebo recipients (13% vs. 17%) but a significantly higher rate of bone fractures (2.9% vs. 1.5%).


After the FLAME study, some clinicians jumped on the bandwagon and began routinely prescribing SSRIs to patients poststroke, even patients without depression. These results call into question the practice of routine SSRI use. The authors were unable to identify a subgroup that showed benefit. Ongoing studies will also evaluate use of fluoxetine after stroke. Until these data are available, SSRI use can be justified for poststroke depression, but for the promotion of functional recovery it could be wishful thinking.

Seemant Chaturvedi, MD reviewing FOCUS Trial Collaboration. Lancet 2018 Dec 5


FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): A pragmatic, double-blind, randomised, controlled trial. Lancet 2018 Dec 5; [e-pub].

[Free full-text Lancet article]

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