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  • Lundström, Erik,Docent,1964-Uppsala universitet,Uppsala University,Uppsala University Hospital,Landtblom: Neurovetenskap (author)

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

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2020-02-28
  • Uppsala :Springer Science and Business Media LLC,2020

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/291959
  • https://gup.ub.gu.se/publication/291959URI
  • https://doi.org/10.1186/s13063-020-4124-7DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-169380URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-271541URI
  • https://lup.lub.lu.se/record/752d22ea-f4fe-4f2c-93db-95833ab9e3b7URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-443646URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-408191URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:143169557URI

Supplementary language notes

  • Language:English

Part of subdatabase

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Correction: Lundström, E., Isaksson, E., Näsman, P. et al. Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden. Trials 21, 388 (2020). DOI: 10.1186/s13063-020-04327-w
  • Correction in: 10.1186/s13063-020-4124-7WOS: 000518631900003QC 20200427QC 20210915
  • Correction in: TRIALS, Volume: 21, Issue: 1, Article Number: 388, DOI: 10.1186/s13063-020-04327-w
  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Isaksson, E.Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, Neurol, Nobels Vag 6, SE-17176 Stockholm, Sweden (author)
  • Näsman, PerKTH Royal Institute of Technology,KTH,Fastighetsekonomi och finans,KTH Royal Inst Technol, Ctr Safety Res, TR10 B, SE-10044 Stockholm, Sweden(Swepub:kth)u1ghoqwp (author)
  • Wester, Per,1959-Karolinska Institutet,Umeå University,Umeå universitet,Avdelningen för medicin,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden,Karolinska Inst, Danderyd Hosp, Dept Clin Sci, SE-18288 Stockholm, Sweden.;Umeå Univ, Dept Publ Hlth & Clin Med, SE-90187 Umeå, Sweden.(Swepub:umu)pewe0002 (author)
  • Martensson, B.Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, SE-17177 Stockholm, Sweden (author)
  • Norrving, BoLund University,Lunds universitet,Klinisk strokeforskning,Forskargrupper vid Lunds universitet,Stroke policy och kvalitetsregisterforskning,Clinical Stroke Research Group,Lund University Research Groups,Stroke policy and quality register research,Skåne University Hospital,Lund Univ, Skane Univ Hosp, Dept Clin Sci, Neurol, SE-22185 Lund, Sweden(Swepub:lu)neur-bno (author)
  • Wallen, H.Karolinska Institutet,Karolinska Institute,Danderyd Hospital,Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Div Cardiovasc Med, SE-18288 Stockholm, Sweden (author)
  • Borg, JörgenKarolinska Institutet(Swepub:lu)medk-jbo (author)
  • Dennis, M.Univ Edinburgh, Royal Infirm, Edinburgh EH16 4SB, Scotland.,University of Edinburgh (author)
  • Mead, G.Univ Edinburgh, Royal Infirm, Edinburgh EH16 4SB, Scotland.,University of Edinburgh (author)
  • Hankey, G. J.Univ Western Australia, Med Sch, Perth, Australia.,University of Western Australia, Crawley (author)
  • Hackett, M. L.Univ New South Wales Sydney, George Inst Global Hlth, Fac Med, Sydney, Australia.;Univ Cent Lancashire, Preston, England.,University of New South Wales,University of Central Lancashire (author)
  • Stibrant Sunnerhagen, Katharina,1957Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology,Univ Gothenburg, Inst Neurosci & Physiol, Sahlgrenska Acad, Gothenburg, Sweden.;Riga Stradins Univ, Riga, Latvia.;Sunnaas Rehabil Hosp, Bjornemy, Norway.;Sahlgrens Univ Hosp, Rehabil Med, Gothenburg, Sweden.,Riga Stradins University,Sahlgrenska University Hospital,Sahlgrenska Academy(Swepub:gu)xstika (author)
  • Effects Trial Collaboration, Effects Trial Collaboration (author)
  • Wiberg, Bernice,1956-Uppsala universitet,Geriatrik(Swepub:uu)bewib534 (author)
  • Uppsala UniversityUppsala University Hospital (creator_code:org_t)

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  • In:TrialsUppsala : Springer Science and Business Media LLC21:11745-6215

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