Plain English Summary
Background and study aims
Fluoxetine is an effective and safe drug which has been successfully used for many years to relieve depression. There is now also evidence from small trials that fluoxetine might have other effects on the brain e.g. generation of new brain cells, which might help patients make a better recovery from the physical effects of their stroke. For example, a recent small trial from France suggested that fluoxetine might improve the recovery of strength in stroke patients with residual arm weakness. The aim of this trial is to find out whether fluoxetine, given for 6 months, improves recovery if started in stroke patients who are between 2 and 15 days after their stroke.
Who can participate?
Stroke patients who had a stroke between 2 and 15 days previously can participate, providing they are at least 18 years of age, have had a brain scan that is compatible with a stroke (either due to a bleed or a blood clot in the brain), and still have some residual problems caused by the stroke e.g. weakness in the arm or leg. Stroke patients cannot participate if they are taking medication that might interact with fluoxetine, e.g. a selective serotonin reuptake inhibitor (a type of antidepressant), or if they have had seizures in the past or if they are seriously ill with other medical problems.
What does the study involve?
Researchers will collect information about the type of stroke the patients have had. Then, half the patients will be randomly allocated to fluoxetine capsules for 6 months, and the other half to an identical 'placebo' capsule for 6 months. At hospital discharge, or at 1 month for patients who did not require hospital admission, the researchers will check whether participants are still taking the trial capsules and whether they have experienced any adverse effects. At 3 months, the researchers will contact the participants to check whether they are still taking the capsules, and ask about adverse effects. At six and 12 months after recruitment, participants will be asked to complete questionnaires about their overall recovery from the stroke, and about common problems after stroke e.g. weakness in limbs, memory problems, problems with speech, low mood. These questionnaires can be completed on paper, via the secure trial website or by telephone. If patients cannot complete the forms themselves, their next of kin or carer will be asked to do this. General practitioners will also be contacted at 6 months and 12 months to enquire about any medical problems and use of health care resources e.g. attendance at hospital, new medications. Patients' involvement will end 12 months after recruitment. The researchers will collect data on long-term recovery through national statistics.
What are the possible benefits and risks of participating?
If fluoxetine improves recovery from stroke, those patients allocated fluoxetine may have benefited. However, fluoxetine may have side effects and it may not improve recovery from stroke.
Where is the study run from?
University of Edinburgh and NHS Lothian (UK)
When is the study starting and how long is it expected to run for?
The study will start recruiting patients in July 2012, and will recruit for about four years. Patients will be followed up for 1 year. The study is likely to end in October 2017.
Who is funding the study?
The Stroke Association (UK)
Who is the main contact?
Dr Gillian Mead
gmead@staffmail.ed.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Gillian Mead
ORCID ID
Contact details
Royal Infirmary
49 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 6481
gmead@staffmail.ed.ac.uk
Additional identifiers
EudraCT number
2011-005616-29
ClinicalTrials.gov number
Protocol/serial number
FOCUS2012
Study information
Scientific title
Fluoxetine Or Control Under Supervision (FOCUS): a multicentre randomised trial to establish the effect(s) of routine administration of Fluoxetine in patients with a recent stroke
Acronym
FOCUS
Study hypothesis
The routine administration of fluoxetine (20 mg daily) for 6 months after an acute stroke will improve patients' functional outcome.
Ethics approval
Scotland A Research Ethics Committee, 21/12/2011, ref: 11/SS/0100
Study design
Multicentre parallel-group double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Ischaemic or haemorrhagic stroke
Intervention
Fluoxetine 20 mg once daily or matching placebo capsules for 6 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fluoxetine
Primary outcome measure
Modified Rankin scale at 6 months
Secondary outcome measures
1. Deaths from all causes at 6 and 12 months
2. Modified Rankin scale at 12 months
3. Stroke Impact Scale
4. Euroquol 5D-5L
5. Mental Health Inventory 5
6. Vitality subscale of SF36 (as an assessment of fatigue)
7. Diagnosis of depression
8. Other adverse events
9. Adherence to the trial medication
10. Health and social care resources used during follow up
Overall trial start date
01/07/2012
Overall trial end date
01/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Brain imaging is compatible with intracerebral haemorrhage or ischaemic stroke
3. Randomisation can be performed between 2 and 15 days after stroke onset
4. Persisting focal neurological deficit is present at the time of randomisation severe enough to warrant 6 months trial treatment from the patient's or carer's perspective
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
Total final enrolment
3127
Participant exclusion criteria
1. Subarachnoid haemorrhage
2. Unlikely to be available for follow up at 12 months
3. Patient and/or carer unable to understand spoken or written English
4. Other life-threatening illness
5. Pregnant or breast-feeding or of child bearing age not taking contraception
6. History of epileptic seizures
7. Attempted suicide or self-harm
8. Allergy or contra indication to fluoxetine
9. Taken a monoamine oxidase inhibitor in last 5 weeks
10. Current or recent depression requiring treatment with selective serotonin reuptake inhibitor
11. Already participating in a Clinical Trial of an Investigational Medical Product
Recruitment start date
01/07/2012
Recruitment end date
31/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Infirmary
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
University of Edinburgh and NHS Lothian (UK)
Sponsor details
c/co Marise Bucukoglu
ACCORD
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Stroke Association ref: TSA 2011101
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal and announcement of results at the UK stroke forum meeting.
IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26289352
2017 statistical and health economic analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/29282099
2019 results in http://www.ncbi.nlm.nih.gov/pubmed/30528472
2019 exploratory analyses in https://www.ncbi.nlm.nih.gov/pubmed/31426731 (added 01/04/2020)
2020 results in https://pubmed.ncbi.nlm.nih.gov/32452356/ (added 27/05/2020)