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; Wallén, Håkan; Borg, Jörgen; Dennis, Martin; Mead, Gillian; Hankey, Graeme J.; Hackett, Maree L.; Sunnerhagen, Katharina S.

doi:10.1186/s13063-020-4124-7

Cited by 6 publications

(6 citation statements)

References 14 publications

(15 reference statements)

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“…In this explorative and prospective, longitudinal study we collected data on all patients treated for stroke at the Sahlgrenska University Hospital in Gothenburg, who were also included in the Swedish Efficacy oF Fluoxetine—a randomisEd Controlled Trial in Stroke (EFFECTS; NCT02683213) 22 . The EFFECTS was an investigator-led, multicenter, randomized, placebo-controlled, double-blind, parallel group trial with the objective to investigate whether fluoxetine could improve recovery and quality of life after stroke.…”

Section: Methodsmentioning

confidence: 99%

Levels of physical activity before and after stroke in relation to early cognitive function

Viktorisson

Andersson

Lundström

et al. 2021

Sci Rep

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Regular physical activity is widely recommended in the primary and secondary prevention of stroke. Physical activity may enhance cognitive performance after stroke, but cognitive impairments could also hinder a person to take part in physical activity. However, a majority of previous studies have not found any association between post-stroke cognitive impairments and a person’s subsequent level of activity. In this explorative, longitudinal study, we describe the intraindividual change in physical activity from before to 6 months after stroke, in relation to early screening of post-stroke cognitive impairments. Participants were recruited at 2 to 15 days after stroke, and screened for cognitive impairments using the Montreal Cognitive Assessment tool. Information on pre-stroke physical activity was retrospectively collected at hospital admittance by physiotherapists. Post-stroke physical activity was evaluated after 6 months. Of 49 participants included, 44 were followed up. The level of physical activity changed in more than half of all participants after stroke. Participants who were physically active 6 months after stroke presented with significantly less cognitive impairments. These results highlight that many stroke survivors experience a change in their physical activity level following stroke, and that unimpaired cognition may be important for a stroke survivors’ ability to be physically active.

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Section: Methodsmentioning

confidence: 99%

Levels of physical activity before and after stroke in relation to early cognitive function

Viktorisson

Andersson

Lundström

et al. 2021

Sci Rep

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“…The design, methods, and primary results of the EFFECTS trial have been published. 3,[6][7][8] Briefly, EFFECTS was a randomized, double-blind, placebo-controlled clinical trial conducted in 35 hospital stroke units in Sweden. The trial was approved by a central medical ethics committee in Stockholm (reference 2013/1265-31/2) and by the Swedish Medical Agency (reference 5.1-2014-43006); all patients provided written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…3 EFFECTS included 1500 stroke patients from Sweden, and the results were similar to those of 2 other large randomized controlled trials with comparable design. 4,5 As specified in the protocol 6,7 and statistical analysis plan, 8 we followed-up participants to 12 months, to examine whether any effects of fluoxetine identified at 6 months were sustained or delayed.…”

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confidence: 99%

Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke

Lundström

Isaksson

Greilert-Norin

et al. 2021

Stroke

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Background and Purpose: The EFFECTS (Efficacy of Fluoxetine—a Randomised Controlled Trial in Stroke) recently reported that 20 mg fluoxetine once daily for 6 months after acute stroke did not improve functional outcome but reduced depression and increased fractures and hyponatremia at 6 months. The purpose of this predefined secondary analysis was to identify if any effects of fluoxetine were maintained or delayed over 12 months. Methods: EFFECTS was an investigator-led, randomized, placebo-controlled, double-blind, parallel group trial in Sweden that enrolled adult patients with stroke. Patients were randomized to 20 mg oral fluoxetine or matching placebo for 6 months and followed for another 6 months. The primary outcome was functional outcome (modified Rankin Scale), at 6 months. Predefined secondary outcomes for these analyses included the modified Rankin Scale, health status, quality of life, fatigue, mood, and depression at 12 months. Results: One thousand five hundred patients were recruited from 35 centers in Sweden between 2014 and 2019; 750 were allocated fluoxetine and 750 placebo. At 12 months, modified Rankin Scale data were available in 715 (95%) patients allocated fluoxetine and 712 (95%) placebo. The distribution of modified Rankin Scale categories was similar in the 2 groups (adjusted common odds ratio, 0.92 [95% CI, 0.76–1.10]). Patients allocated fluoxetine scored worse on memory with a median value of 89 (interquartile range, 75–100) versus 93 (interquartile range, 82–100); P =0.0021 and communication 93 (interquartile range, 82–100) versus 96 (interquartile range, 86–100); P =0.024 domains of the Stroke Impact Scale compared with placebo. There were no other differences in secondary outcomes. Conclusions: Fluoxetine after acute stroke had no effect on functional outcome at 12 months. Patients allocated fluoxetine scored worse on memory and communication on the Stroke Impact Scale compared with placebo, but this is likely to be due to chance. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02683213.

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“…Our monitors cross-checked the counting for 10% of the patients. 10 Our monitors crosschecked the counting for 10% of the patients. 10 The median duration of treatment was 180 days (IQR 180-180) for both groups.…”

Section: Role Of the Funding Sourcementioning

confidence: 99%

“…10 Our monitors crosschecked the counting for 10% of the patients. 10 The median duration of treatment was 180 days (IQR 180-180) for both groups. About 89% (1338/1500) took the study medication for at least 150 days.…”

Section: Role Of the Funding Sourcementioning

confidence: 99%

Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial

Lundström¹,

Isaksson²,

Näsman³

et al. 2020

The Lancet Neurology

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BACKGROUNDPrevious studies have suggested that fluoxetine could improve neurological recovery after stroke. The EFFECTS trial was designed to test the hypothesis that administration of fluoxetine for 6 months after acute stroke would improve functional outcome. METHODSEFFECTS was an investigator-led, parallel group, randomised, placebo-controlled trial that enrolled non-depressed stroke patients aged 18 years or older between two and 15 days after stroke onset in 35 hospitals in Sweden. The patients had a clinical diagnosis of ischemic or intracerebral haemorrhage with persisting focal neurological deficits at inclusion. A webbased randomisation system which incorporated a minimisation algorithm was used to allocate participants to fluoxetine 20 mg once daily or matching placebo capsules for 6 months with a ratio of 1:1. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months. Patients were analysed according to their treatment allocation. EFFECTS is registered with ClinicalTrials.gov, number NCT02683213. FINDINGS Recruitment started 20 Oct 2014 and ended 28 June 2019, when the planned 1500 patients were included (750 to fluoxetine and 750 to placebo). mRS data were available for 737/750 (98%) in the fluoxetine group and 742/750 (99%) in the placebo group. The primary outcome -distribution across mRS categories-was neutral (common odds ratio adjusted for minimisation variables 0•94 [95% CI 0•78 to 1•13], p=0•42). Fluoxetine reduced depression

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

Cited by 6 publications

References 14 publications

Levels of physical activity before and after stroke in relation to early cognitive function

Levels of physical activity before and after stroke in relation to early cognitive function

Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke

Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial

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