Fluoxetine Or Control Under Supervision (FOCUS) trial: to establish the effect(s) of routine administration of Fluoxetine in patients with a recent stroke
| ISRCTN | ISRCTN83290762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83290762 |
| EudraCT/CTIS number | 2011-005616-29 |
| Secondary identifying numbers | FOCUS2012 |
- Submission date
- 16/05/2012
- Registration date
- 23/05/2012
- Last edited
- 27/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Royal Infirmary
49 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
| Phone | +44 (0)131 242 6481 |
|---|---|
| gmead@staffmail.ed.ac.uk |
Study information
| Study design | Multicentre parallel-group double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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 |
| Study acronym | FOCUS |
| Study objectives | The routine administration of fluoxetine (20 mg daily) for 6 months after an acute stroke will improve patients' functional outcome. |
| Ethics approval(s) | Scotland A Research Ethics Committee, 21/12/2011, ref: 11/SS/0100 |
| Health condition(s) or problem(s) studied | Ischaemic or haemorrhagic stroke |
| Intervention | Fluoxetine 20 mg once daily or matching placebo capsules for 6 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2012 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Total final enrolment | 3127 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
EH16 4SA
United Kingdom
Sponsor information
University/education
c/co Marise Bucukoglu
ACCORD
The Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Website | http://www.accord.ed.ac.uk |
|---|---|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/08/2015 | Yes | No | |
| Other publications | statistical and health economic analysis plan | 28/12/2017 | Yes | No | |
| Results article | results | 19/01/2019 | Yes | No | |
| Other publications | exploratory analyses | 01/11/2019 | 01/04/2020 | Yes | No |
| Results article | results | 01/05/2020 | 27/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/05/2020: Publication reference added.
01/04/2020: Publication reference added.
14/06/2019: Publication reference and total final enrolment number added.
15/10/2018: The following updates were made:
1. The publication and dissemination plan was added.
2. The IPD sharing statement was added.
3. The participant level data was added.
4. The recruitment end date was changed from 01/07/2016 to 31/03/2017.
12/10/2018: The intention to publish date was added.
14/02/2018: Publication reference added.
05/05/2016: Publication reference added.
