Evidence map›Paper›PMID 32452356›Full record

Trial reportHealth technology assessment (Winchester, England)2020

Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.

Martin Dennis, John Forbes, Catriona Graham, Maree Hackett, Graeme J Hankey, Allan House, Stephanie Lewis, Erik Lundström, Peter Sandercock, Gillian Mead

Open access · diamondAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
1.7field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Individual patient data meta-analysis of the effects of fluoxetine on functional outcomes after acute stroke.International journal of stroke : official journal of the International Stroke Society · 2024
    Pooled it
  3. Pooled it
  4. Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Review
  6. Review
  7. Interventions for Neural Plasticity in Stroke Recovery.Archives of internal medicine research · 2025
    Article
  8. Article
  9. Article
  10. Advancement of epigenetics in stroke.Frontiers in neuroscience · 2022
    Review
  11. Review
  12. The 2020 Yearbook of Neurorestoratology.Journal of neurorestoratology · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Martin DennisCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.ORCID 0000-0003-1148-8972
John ForbesHealth Research Institute, University of Limerick, Limerick, Ireland.ORCID 0000-0002-8255-3762
Catriona GrahamEdinburgh Clinical Research Facility, University of Edinburgh, Edinburgh, UK.ORCID 0000-0003-1889-712X
Maree HackettThe George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.ORCID 0000-0003-1211-9087
Graeme J HankeyMedical School, University of Western Australia, Crawley, WA, Australia.ORCID 0000-0002-6044-7328
Allan HouseInstitute of Health Sciences, University of Leeds, Leeds, UK.ORCID 0000-0001-8721-8026
Stephanie LewisEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.ORCID 0000-0003-1210-2314
Erik LundströmDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-5313-9052
Peter SandercockCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-8484-0135
Gillian MeadCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-7494-2023
University of Edinburgh · GBThe University of Western Australia · AUUniversity of Leeds · GBUniversity of Limerick · IEUNSW Sydney · AUUppsala University · SE

Funding

Department of Health 13/04/30
6 · The paper itself

Abstract

backgroundOur Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias.

objectivesThe Fluoxetine Or Control Under Supervision (FOCUS) trial tested the hypothesis that fluoxetine improves recovery after stroke.

designThe FOCUS trial was a pragmatic, multicentre, parallel-group, individually randomised, placebo-controlled trial.

settingThis trial took place in 103 UK hospitals.

participantsPatients were eligible if they were aged ≥ 18 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset.

interventionsPatients were randomly allocated 20 mg of fluoxetine once per day or the matching placebo for 6 months via a web-based system using a minimisation algorithm.

main outcome measuresThe primary outcome was the modified Rankin Scale at 6 months. Patients, carers, health-care staff and the trial team were masked to treatment allocation. Outcome was assessed at 6 and 12 months after randomisation. Patients were analysed by their treatment allocation as specified in a published statistical analysis plan.

resultsBetween 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated fluoxetine and 1563 of whom were allocated placebo. The modified Rankin Scale score at 6 months was available for 1553 out of 1564 (99.3%) of those allocated fluoxetine and 1553 out of 1563 (99.4%) of those allocated placebo. The distribution across modified Rankin Scale categories at 6 months was similar in the two groups (common odds ratio adjusted for minimisation variables 0.951, 95% confidence interval 0.839 to 1.079; LIMITATIONS: Some non-adherence to trial medication, lack of face-to-face assessment of neurological status at follow-up and lack of formal psychiatric diagnosis during follow-up.

conclusions20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients' functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients' characteristics and health-care setting.

trial registrationCurrent Controlled Trials ISRCTN83290762.

fundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in

Indexed as

AdultFemaleFluoxetineHumansMaleMiddle AgedQuality of LifeRecovery of FunctionSelective Serotonin Reuptake InhibitorsStrokeSurveys and QuestionnairesUnited KingdomFluoxetineSelective Serotonin Reuptake InhibitorsDECISION-MAKINGDEPRESSIONDEPRESSIVE DISORDERFLUOXETINEFRACTURES, BONEHOSPITALSHUMANSMOOD DISORDERSPHYSICAL RECOVERYRANDOMISED TRIALSTROKETREATMENT OUTCOME

Identifiers

PMID32452356
PMCPMC7294394
OpenAlexW3030456261

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.