Evidence map›Paper›PMID 32111264›Full record

ArticleTrials2020

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

Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead and 4 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02683213 (Establishing the Effect), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02683213 phase3completednot on this map

Establishing the Effect(s) and Safety of Fluoxetine Initiated in the Acute Phase of Stroke

TypeinterventionalSponsorKarolinska InstitutetRan2014 to 2020Enrolled1,500ConditionsStrokeArmsFluoxetine, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Erik LundströmDepartment of Neuroscience, Neurology, Uppsala University, Akademiska Sjukhuset, SE-751 85, Uppsala, Sweden. erik.lundstrom@neuro.uu.se.ORCID http://orcid.org/0000-0002-5313-9052
Eva IsakssonDepartment of Clinical Neuroscience, Neurology, Karolinska Institutet, Nobels väg 6, SE-171 76, Stockholm, Sweden.
Per NäsmanCentre for Safety Research, KTH Royal Institute of Technology, TR10 B, SE-100 44, Stockholm, Sweden.
Per WesterDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
Björn MårtenssonDepartment of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
Bo NorrvingDepartment of Clinical Sciences, Lund, Neurology, Skåne University Hospital, Lund University, SE-221 85, Lund, Sweden.
Håkan WallénDepartment of Clinical Sciences, Division of Cardiovascular Medicine, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
Jörgen BorgDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
Martin DennisRoyal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.
Gillian MeadRoyal Infirmary, University of Edinburgh, Edinburgh, EH16 4SB, UK.
Graeme J HankeyMedical School, The University of Western Australia, Perth, Australia.
Maree L HackettThe George Institute for Global Health, Faculty of Medicine, University of New South Wales Sydney, Sydney, Australia.
Katharina S SunnerhagenInstitute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
EFFECTS Trial Collaboration

Funding

Hjärnfonden FO2017-0115Hjärt-Lungfonden 2013-0496Hjärt-Lungfonden 2016-0245Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse 2014STROKE-Riksförbundet 2012_2013Svenska Läkaresällskapet ID 692921Svenska Läkaresällskapet ID 692921_2Vetenskapsrådet (SE) 2014-07072
6 · The paper itself

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.

methodsIn 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.

resultsSeven 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.

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

Indexed as

Clinical Trials, Phase III as TopicDrug Administration ScheduleFluoxetineHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicRecovery of FunctionSelective Serotonin Reuptake InhibitorsStrokeSwedenTime FactorsTreatment OutcomeFluoxetineSelective Serotonin Reuptake InhibitorsFluoxetineMulticentre studyRecovery of functionSelective serotonin reuptake inhibitorSSRIStrokeStroke recovery

Identifiers

PMID32111264
PMCPMC7048055

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Registered trials

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.