Published full papers in peer-reviewed journals
- Gillian Mead , Maree Hackett , Erik Lundström , Veronica Murray , Graeme J Hankey, and Martin Dennis. The FOCUS,AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials. Trials. 2015 20 (16):369. PubMed PMID:26289352. Click here.
Catrion Graham, Steff Lewis, John Forbes, Gillian Mead, Maree L. Hackett, Graeme J. Hankey, John Gommans, Huy Thang Nguyen, Erik Lundström, Eva Isaksson, Per Näsman, Ann-Sofie Rudberg, and Martin Dennis. The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis. Trials. 2017 18:627. DOI 10.1186/s13063-017-2385-6.
An article about the Statistical Analysis Plan for FOCUS, EFFECTS och AFFINITY.Trials 2017, 18(1):627. PMID 29282099. Click here.
- Erik Lundström, Eva Isaksson, Per Wester, Ann-Charlotte Laska, and Per Näsman. Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised stepped wedge cluster trial within the EFFECTS trial. Trials 2018 19:14. Click here.
- Eva Isaksson, Per Wester, Ann-Charlotte Laska, Per Näsman, and Erik Lundström. Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel. Trials. 2019. 20, 618 . Click here.
- Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J Hankey, Maree Hackett, and Katharina Stibrant Sunnerhagen. Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden. Trials 2020: 21:233. Click here.
- Ann-Sofie Rudberg, Eivind Berge, Ann-Charlotte Laska, Stina Jutterström, Per Näsman, Katharina S Sunnerhagen, and Erik Lundström. Stroke survivors’ priorities for research related to life after stroke. Topics in Stroke Rehabilitation. Click here.
- Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J Hankey, Maree L Hackett, and Katharina S Sunnerhagen. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurology 2020 Aug;19(8):661-669. Click here.
- Eva Isaksson, Per Wester, Ann-Charlotte Laska, Per Näsman, and Erik Lundström. Validation of the simplified modified Rankin Scale questionnaire. In Press. Accepted in European Neurology, 5 Aug 2020.
Papers under review
- Gillian Mead, Catriona Graham, Laurent Biot, Per Näsman, Erik Lundström, Steff Lewis, Graeme J Hankey, Maree L Hackett, John Forbes, and Martin Dennis. Update on the statistical analysis plan for an individual patient data meta-analysis (IPDM) for three large trials of fluoxetine for stroke recovery. Submitted May 2020.
- Adam Viktorisson, Elisabeth M Andersson, Erik Lundström, Katharina S Sunnerhagen. Levels of physical activity before and after stroke in relation to cognitive function: a prospective study in Sweden. American Journal of Physical Medicine & Rehabilitation. Submitted 07 July 2020.
Correspondence since 2013
- Gillian Mead, Martin Dennis, Erik Lundström, Veronica Murray , Maree L Hackett, and Graeme J Hankey. Letter by Mead. Selective serotonin reuptake inhibitors for stroke:
more trials are needed. Stroke. 2013 Apr;44(4):e40-1. doi:
10.1161/STROKEAHA.112.681130. Epub 2013 Jan 22. PubMed PMID: 23339962
Editorials and commentaries on EFFECTS since 2020
- Gert Kwakkel, Carel G M Meskers, and Nick S Ward. Time for the next stage of stroke recovery trials.Lancet Neurology Volume 19, Issue 8, August 2020, Pages 636-637.
Abstracts published since 2013
- ESOC 2014
- ESOC 2016
- ESOC 2019. You find the poster here and the Abstract is published in the European Stroke Journal, Abstract number AS-36-014 entitled UPDATE ON THE EFFECTS TRIAL OF FLUOXETINE FOR STROKE RECOVERY: AN INVESTIGATOR-LED RANDOMISED CONTROLLED STUDY IN SWEDEN. European Stroke Journal. Volume 4 Issue 1_suppl, May 2019. First Published May 22, 2019.
- ESOC 2020. Efficacy of fluoxetine – a randomised controlled trial in stroke (EFFECTS). Presented at a webinar 13 May 2020. EFFECTS and AFFINITY were selected as two of the five highest-rated research works at the joint ESO-WSO Conference. Also planned at Large Clinical Trials ,7 Nov 2020 in Vienna.
- Half-time control 12 September 2018 at Karolinska Institutet, Sweden
- Half-time control 14 December 2018 at Karolinska Institutet, Sweden
- Registered Jan 2019 at Uppsala University, Sweden
Publication plan (preliminary)
- The MAP EFFECTS study. This is an exploratory study of neural mechanisms of fluoxetine mediated motor, cognitive, and language recovery after stroke. We aiming to do a Trial Within a Study (TWIST), using the EFFECTS as the mother study.
- Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery. Legg LA, Tilney R, Hsieh CF, Wu S, Lundström E, Rudberg AS, Kutlubaev MA, Dennis M, Soleimani B, Barugh A, Hackett ML, Hankey GJ, Mead GE. Cochrane Database Syst Rev. 2019 Nov 26;2019(11). doi: 10.1002/14651858.CD009286.pub3. Review.
Publications from our sister trials FOCUS and AFFINITY
- Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet. Published online December 5, 2018. Open Access.
- Abstract and ePoster on fractures and fluoxetine (THE EFFECTS OF FLUOXETINE ON FRACTURE RISK AFTER STROKE – FURTHER ANALYSES FROM THE FOCUS TRIAL)
- Martin Dennis, John Forbes, Catriona Graham, Maree L. Hackett, Graeme J. Hankey, Allan House, Steff Lewis, Erik Lundström, Peter Sandercock, Gillian Mead. Fluoxetine and Fractures After Stroke. Exploratory Analyses From the FOCUS Trial. Stroke. 20 Aug 2019. Click here.
- Gillian Mead, Lynn Legg, Russel Tilney, Cheng Fang Hsieh, Simiao Wu, Erik Lundström, Ann Sofie Rudberg, Mansur Kutlubaev, Martin S Dennis, Babak Soleimani, Amanda Barugh, Maree L. Hackett and Graeme J. Hankey. Fluoxetine for stroke recovery: meta-analysis of randomised controlled trials. International Journal of Stroke. Click here.
- Martin Dennis, John Forbes , Catriona Graham, Maree Hackett , Graeme Hankey, Allan House A, Steff Lewi, Erik Lundström, Peter Sandercock, Gillian Mead. Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT. Health Technology Assessment 2020;24(22). Click here.
- Graeme J Hankey, Maree L Hackey, Osvaldo P. Almeida, Leon Flicker, Gillian E Mead, Martin S. Dennis, Christopher Eheron-Beer, Andre H. Ford, Laren Billo, Sephen Jan, Erik Lundström, Craig S. Anderson, H Thang-Ngen, John Gommans, Qilong Yi, Thomas Lng. Safety and efficacy of fluoxetine on functional recovery after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial. Lancet Neurology 2020 Aug;19(8) 651-679. Click here.