Overview

Efficacy of Fluoxetine - a Trial in Stroke

Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate whether routine administration of fluoxetine 20mg once daily in the 6 months initiated during the acute stroke improves the patient's functional outcome. EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind placebo controlled trial with broad entry criteria and follow up at 6 and 12 months. EFFECTS managed to recruit its anticipated numbers of 1,500 participants between 20th October 2014 and 28th June 2019. Data will be unblinded when the 6-months follow-up is completed, and the primary outcome is due to report on May 2020.
Phase:
Phase 3
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Hjärnfonden (The Swedish Brain foundation)
Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
Stroke-Riksförbundet
Swedish Heart Lung Foundation
The Swedish Medical Association
The Swedish Research Council
Treatments:
Fluoxetine