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Update on the EFFECTS study of fluoxetine for stroke recovery : A randomised controlled trial in Sweden

Lundström, Erik ; Isaksson, Eva ; Näsman, Per ; Wester, Per ; Mårtensson, Björn ; Norrving, Bo LU ; Wallén, Håkan ; Borg, Jörgen LU ; Dennis, Martin and Mead, Gillian , et al. (2020) In Trials 21(1).
Abstract

Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods: In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological... (More)

Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods: In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological deficits. Patients were randomised to fluoxetine 20 mg or matching placebo capsules once daily for 6 months. Results: Seven amendments were made and included clarification of drug interaction between fluoxetine and metoprolol and the use of metoprolol for severe heart failure as an exclusion criterion, inclusion of data from central Swedish registries and the Swedish Stroke Register, changes in informed consent from patients, and clarification of design of some sub-studies. EFFECTS recruited 1500 patients at 35 centres in Sweden between 20 October 2014 and 28 June 2019. We plan to unblind the data in January 2020 and report the primary outcome in May 2020. Conclusion: EFFECTS will provide data on the safety and efficacy of 6 months of treatment with fluoxetine after stroke in a Swedish health system setting. The data from EFFECTS will also contribute to an individual patient data meta-analysis. 

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Contribution to journal
publication status
published
subject
keywords
Fluoxetine, Multicentre study, Recovery of function, Selective serotonin reuptake inhibitor, SSRI, Stroke, Stroke recovery
in
Trials
volume
21
issue
1
article number
233
publisher
BioMed Central (BMC)
external identifiers
  • pmid:32111264
  • scopus:85080877178
ISSN
1745-6215
DOI
10.1186/s13063-020-4124-7
language
English
LU publication?
yes
id
752d22ea-f4fe-4f2c-93db-95833ab9e3b7
date added to LUP
2020-03-18 14:56:07
date last changed
2021-04-13 01:01:30
@article{752d22ea-f4fe-4f2c-93db-95833ab9e3b7,
  abstract     = {<p>Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods: In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological deficits. Patients were randomised to fluoxetine 20 mg or matching placebo capsules once daily for 6 months. Results: Seven amendments were made and included clarification of drug interaction between fluoxetine and metoprolol and the use of metoprolol for severe heart failure as an exclusion criterion, inclusion of data from central Swedish registries and the Swedish Stroke Register, changes in informed consent from patients, and clarification of design of some sub-studies. EFFECTS recruited 1500 patients at 35 centres in Sweden between 20 October 2014 and 28 June 2019. We plan to unblind the data in January 2020 and report the primary outcome in May 2020. Conclusion: EFFECTS will provide data on the safety and efficacy of 6 months of treatment with fluoxetine after stroke in a Swedish health system setting. The data from EFFECTS will also contribute to an individual patient data meta-analysis. </p>},
  author       = {Lundström, Erik and Isaksson, Eva and Näsman, Per and Wester, Per and Mårtensson, Björn and Norrving, Bo and Wallén, Håkan and Borg, Jörgen and Dennis, Martin and Mead, Gillian and Hankey, Graeme J. and Hackett, Maree L. and Sunnerhagen, Katharina S.},
  issn         = {1745-6215},
  language     = {eng},
  month        = {02},
  number       = {1},
  publisher    = {BioMed Central (BMC)},
  series       = {Trials},
  title        = {Update on the EFFECTS study of fluoxetine for stroke recovery : A randomised controlled trial in Sweden},
  url          = {http://dx.doi.org/10.1186/s13063-020-4124-7},
  doi          = {10.1186/s13063-020-4124-7},
  volume       = {21},
  year         = {2020},
}