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

Not Applicable

Completed

• Conditions: Ischaemic or haemorrhagic stroke; Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN83290762
• Lead Sponsor: niversity of Edinburgh and NHS Lothian (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-23
• Study Completion: 2017-10-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3127

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale at 6 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Deaths from all causes at 6 and 12 months<br> 2. Modified Rankin scale at 12 months<br> 3. Stroke Impact Scale<br> 4. Euroquol 5D-5L<br> 5. Mental Health Inventory 5<br> 6. Vitality subscale of SF36 (as an assessment of fatigue)<br> 7. Diagnosis of depression<br> 8. Other adverse events<br> 9. Adherence to the trial medication<br> 10. Health and social care resources used during follow up<br>