ISRCTN - ISRCTN83290762: Fluoxetine Or Control Under Supervision (FOCUS) trial: to establish the effect(s) of routine administration of Fluoxetine in patients with a recent stroke

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

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 below 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 measures

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

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

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

01/07/2016

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