. 2020 Feb 28;21(1):233.

doi: 10.1186/s13063-020-4124-7.

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

Erik Lundström¹, Eva Isaksson², Per Näsman³, Per Wester^{4

5}, Björn Mårtensson⁶, Bo Norrving⁷, Håkan Wallén⁸, Jörgen Borg⁴, Martin Dennis⁹, Gillian Mead⁹, Graeme J Hankey¹⁰, Maree L Hackett^{11

12}, Katharina S Sunnerhagen^{13

14

15

16}; EFFECTS Trial Collaboration

Collaborators, Affiliations

Collaborators

Affiliations

¹ Department of Neuroscience, Neurology, Uppsala University, Akademiska Sjukhuset, SE-751 85, Uppsala, Sweden. erik.lundstrom@neuro.uu.se.
² Department of Clinical Neuroscience, Neurology, Karolinska Institutet, Nobels väg 6, SE-171 76, Stockholm, Sweden.
³ Centre for Safety Research, KTH Royal Institute of Technology, TR10 B, SE-100 44, Stockholm, Sweden.
⁴ Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁵ Department of Public Health & Clinical Medicine, Umeå University, SE-901 87, Umeå, Sweden.
⁶ Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
⁷ Department of Clinical Sciences, Lund, Neurology, Skåne University Hospital, Lund University, SE-221 85, Lund, Sweden.
⁸ Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁹ Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.
¹⁰ Medical School, The University of Western Australia, Perth, Australia.
¹¹ The George Institute for Global Health, Faculty of Medicine, University of New South Wales Sydney, Sydney, Australia.
¹² The University of Central Lancashire, Preston, UK.
¹³ Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
¹⁴ Riga Stradins University, Riga, Latvia.
¹⁵ Sunnaas Rehabilitation Hospital, Bjørnemy, Norway.
¹⁶ Rehabilitation Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.

PMID: 32111264
PMCID: PMC7048055
DOI: 10.1186/s13063-020-4124-7

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

Erik Lundström et al. Trials. 2020.

. 2020 Feb 28;21(1):233.

doi: 10.1186/s13063-020-4124-7.

Authors

Collaborators

Affiliations

¹ Department of Neuroscience, Neurology, Uppsala University, Akademiska Sjukhuset, SE-751 85, Uppsala, Sweden. erik.lundstrom@neuro.uu.se.
² Department of Clinical Neuroscience, Neurology, Karolinska Institutet, Nobels väg 6, SE-171 76, Stockholm, Sweden.
³ Centre for Safety Research, KTH Royal Institute of Technology, TR10 B, SE-100 44, Stockholm, Sweden.
⁴ Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁵ Department of Public Health & Clinical Medicine, Umeå University, SE-901 87, Umeå, Sweden.
⁶ Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
⁷ Department of Clinical Sciences, Lund, Neurology, Skåne University Hospital, Lund University, SE-221 85, Lund, Sweden.
⁸ Department of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁹ Royal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.
¹⁰ Medical School, The University of Western Australia, Perth, Australia.
¹¹ The George Institute for Global Health, Faculty of Medicine, University of New South Wales Sydney, Sydney, Australia.
¹² The University of Central Lancashire, Preston, UK.
¹³ Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
¹⁴ Riga Stradins University, Riga, Latvia.
¹⁵ Sunnaas Rehabilitation Hospital, Bjørnemy, Norway.
¹⁶ Rehabilitation Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.

PMID: 32111264
PMCID: PMC7048055
DOI: 10.1186/s13063-020-4124-7

Erratum in

Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden.
Lundström E, Isaksson E, Näsman P, Wester P, Mårtensson B, Norrving B, Wallén H, Borg J, Dennis M, Mead G, Hankey GJ, Hackett ML, Sunnerhagen KS; EFFECTS Trial Collaboration. Lundström E, et al. Trials. 2020 May 7;21(1):388. doi: 10.1186/s13063-020-04327-w. Trials. 2020. PMID: 32381037 Free PMC article.

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 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.

Trial registration: EudraCT 2011-006130-16. Registered on 8 August 2014. ISRCTN, ISRCTN13020412. Registered on 19 December 2014. ClinicalTrials.gov: NCT02683213. Retrospectively registered on 2 February 2016.

Keywords: Fluoxetine; Multicentre study; Recovery of function; SSRI; Selective serotonin reuptake inhibitor; Stroke; Stroke recovery.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

PhD students are affiliated to the EFFECTS study.

Currently, we have registered three PhD students for projects associated with the EFFECTS study: Ann-Sofie Rudberg, Eva Isaksson, and Elias Lindvall.

References

1. Johnson CO, Nguyen M, Roth GA, Nichols E, Alam T, Abate D, et al. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18:439–458. doi: 10.1016/S1474-4422(19)30034-1. - DOI - PMC - PubMed
1. Riksstroke. Riksstroke results 2018. Available from: http://www.riksstroke.org/wp-content/uploads/2019/09/Riksstroke_A%CC%8Ar.... Cited 13 Sept 2019.
1. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1545–1602. doi: 10.1016/S0140-6736(16)31678-6. - DOI - PMC - PubMed
1. Chollet F, Tardy J, Albucher J-F, Thalamas C, Berard E, Lamy C, et al. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011;10:123–130. doi: 10.1016/S1474-4422(10)70314-8. - DOI - PubMed
1. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Inter-observer agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–607. doi: 10.1161/01.STR.19.5.604. - DOI - PubMed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Erratum in

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials