Efficacy of Fluoxetine - a Trial in Stroke (EFFECTS)

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ClinicalTrials.gov Identifier: NCT02683213

Recruitment Status : Completed

First Posted : February 17, 2016

Last Update Posted : September 2, 2020

Sponsor:

Collaborators:

The Swedish Research Council

Swedish Heart Lung Foundation

Stroke-Riksförbundet

Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse

Hjärnfonden (The Swedish Brain foundation)

The Swedish Medical Association

Information provided by (Responsible Party):

Erik Lundström, MD, PhD, Karolinska Institutet

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	June 2020
Actual Study Completion Date :	June 2020

Publications:

Mead G, Hackett ML, Lundström E, Murray V, Hankey GJ, Dennis M. 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 Aug 20;16:369. doi: 10.1186/s13063-015-0864-1.

Mead GE, Hsieh CF, Lee R, Kutlubaev MA, Claxton A, Hankey GJ, Hackett ML. Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD009286. doi: 10.1002/14651858.CD009286.pub2. Review. Update in: Cochrane Database Syst Rev. 2019 Nov 26;2019(11):.

Graham C, Lewis S, Forbes J, Mead G, Hackett ML, Hankey GJ, Gommans J, Nguyen HT, Lundström E, Isaksson E, Näsman P, Rudberg AS, Dennis M. 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 Dec 28;18(1):627. doi: 10.1186/s13063-017-2385-6.

Lundström E, Isaksson E, Wester P, Laska AC, Näsman P. Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial. Trials. 2018 Jan 8;19(1):14. doi: 10.1186/s13063-017-2367-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mead GE, Graham C, Billot L, Näsman P, Lundström E, Lewis S, Hankey GJ, Hackett ML, Forbes J, Dennis M; FOCUS, AFFINITY and EFFECTS trialists. Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical analysis plan for the trials and for the individual patient data meta-analysis. Trials. 2020 Nov 25;21(1):971. doi: 10.1186/s13063-020-04875-1.

EFFECTS Trial Collaboration. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):661-669. doi: 10.1016/S1474-4422(20)30219-2.

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. Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden. Trials. 2020 Feb 28;21(1):233. doi: 10.1186/s13063-020-4124-7. Erratum in: Trials. 2020 May 7;21(1):388.

Isaksson E, Wester P, Laska AC, Näsman P, Lundström E. Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel. Trials. 2019 Oct 30;20(1):618. doi: 10.1186/s13063-019-3737-1.

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