This is the English official homepage for EFFECTS. EFFECTS stands for Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke.
EFFECTS is an academic initiated, investigated led multicentre, parallel group, randomised, placebo-controlled trial of fluoxetine for stroke recovery. We adress the following question: Does routine administration of fluoxetine 20mg once daily in the 6 months after an acute stroke improves the patient’s functional outcome
The purpose of our study is to find a new treatment for stroke recovery. The aim is to test an established drug against depression (fluoxetine) to see whether it can improve recovery and quality of life after stroke as smaller studies indicate.
Expected results and benefits for individuals and society
The expected results are better functioning and improved quality of life.
Fluoxetine is inexpensive (only 300 SEK for 6 months’ treatment), simple to administer and generally well tolerated. If it proves effective, it can be implemented when the study is completed, in 2020. It could be available to a wide range of stroke patients, both ischemic and haemorrhagic stroke, and even in low to middle income countries.
The project’s originality and novelty
- We are studying a new mechanism for stroke, selective serotonin re-uptake inhibitors (SSRI), for stroke recovery. We want to test whether routine administration of fluoxetine (20 mg once daily) in the 6 months after an acute stroke improves the patient’s functional outcome.
- An academic-initiated, investigator-led, randomised controlled study (RCT).
- We aim to include 1,500 patients in Sweden, making EFFECTS the largest RCT study of stroke in Sweden.
- A collaboration with FOCUS and AFFINITY, two other international, investigator-led studies, with the same inclusion and exclusion criteria. A meta-analysis of individual patient data is planned.
- It has a pragmatic design, i.e. we investigate if the interventions work in normal practice, with fewer selected patients and a flexible intervention applied as it would be in normal practice, and finally, outcomes that are relevant to patients and society.
- The study includes both ischemic and haemorrhagic stroke.
- Fluoxetine is inexpensive (only 300 SEK for 6 months’ treatment), simple to administer, and generally well tolerated. If it proves effective, it can be implemented quickly in the healthcare system.
- Good track record regarding data quality and inclusion. Reassuringly, we randomise 30 pat/month in average the last 10 months. The EFFECTS study will succeed with its objective to include all patients.