Depression affects 1 in every 3 adults within the first six months after a stroke
[
[1]
]. In addition to being common, it increases the burden of illness and hinders recovery
from stroke [
[2]
], so that adequate measures to treat and prevent depression in this population are
needed. The results of the fluoxetine in motor recovery of patients with acute ischaemic
stroke (FLAME) trial (n = 118) showed that stroke survivors treated with fluoxetine
had better motor function than their counterparts treated with placebo for 3 months
[
[3]
]. Three large randomised placebo-controlled trials were subsequently designed to
confirm these preliminary findings: the fluoxetine or control under supervision (FOCUS)
trial (n = 3127), the assessment of fluoxetine in stroke recovery (AFFINITY) trial
(n = 1280), and the efficacy of fluoxetine randomised controlled trial in stroke (EFFECTS)
(n = 1500) [
4
,
5
,
6
]. The three trials found that daily treatment with 20 mg of fluoxetine for 6 months
after acute stroke does not improve functional outcomes, but increases the risk of
bone fractures [
4
,
5
,
6
]. These findings raised significant concerns regarding the safe use of fluoxetine
in this population, but need to be balanced against potential benefits, such as the
prevention of depression.Keywords
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References
- Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies.Int. J. Stroke. 2014; 9: 1017-1025
- The impact of poststroke depression on recovery in activities of daily living over a 2-year follow-up.Arch. Neurol. 1990; 47: 785-789
- Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial.Lancet Neurol. 2011; 10: 123-130
- Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial.Lancet Neurol. 2020; 19: 651-660
- Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.Lancet Neurol. 2020; 19: 661-669
- Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial.Lancet. 2019; 393: 265-274
- Serotonin-reuptake inhibitors act centrally to cause bone loss in mice by counteracting a local anti-resorptive effect.Nat. Med. 2016; 22: 1170-1179
- Pharmacological, psychological and non-invasive brain stimulation interventions for preventing depression after stroke.Cochrane Database Syst. Rev. 2020; 5 (CD003689)
- Depression and the risk of fractures in later life: the health in men cohort study.Maturitas. 2021; 145: 6-11
- Neuroregeneration and vascular protection by citalopram in acute ischemic stroke (TALOS).Stroke. 2018; 49: 2568-2576
- Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis.Ann. Intern. Med. 2008; 148: 197-213
Article info
Publication history
Published online: February 24, 2021
Received:
January 18,
2021
Identification
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© 2021 Elsevier B.V. All rights reserved.
