acute stroke MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Oxactin Capsules 20mg
Product Name: fluoxetine 20mg. (trade name is Oxactin 20mg)
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New acute stroke 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. Stroke deficits limiting function at the time of randomisation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: • <18 years old • Subarachnoid haemorrhage, although where this is secondary to an intracerebral haemorrhage the patient will be eligible • Unlikely to be available for follow-up e.g. no fixed home address. Unable to speak English unless they have a close friend or relative who can act as a translator/interpretor • Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months. • Depression requiring pharmacological treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) Drug. (i.e. the same class of drug as Fluoxetine) • Pregnant or breast-feeding woman, women of child bearing age not taking contraception • History of epileptic seizures • Allergy to, or contraindications to fluoxetine including: o Hepatic failure o Renal failure (eGFR < 30ml/min) o Taken a monoamine oxidase inhibitor in last 5 weeks Co- administration of Fluoxetine and a Mono Amine Oxidase Inhibitors (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the FOCUS trial. Also, any patient needing treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI). We will allow co-enrollment to another CTIMP, providing we can attribute adverse events to each specific IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there a difference in the functional outcome, measured with the modified Rankin score, at 6 months between those treated with fluoxetine (20mg daily) for 6 months after stroke, and those treated with placebo?;Primary end point(s): Is there a difference in the modified Rankin score at 6 months following stroke between those treated with fluoxetine compared to placebo?;Timepoint(s) of evaluation of this end point: 6 months;Secondary Objective: 1. Is there a difference in the long term survival between those treated with fluoxetine versus placebo? 2. Is there a difference in the functional outcome, measured with the modified Rankin score at 12 months between those treated with fluoxetine versus placebo? 3. Is there a difference in motor function at 6 months and 12 months, between those treated with fluoxetine versus placebo? 4. Is there a difference in communication at 6 months and 12 months after stroke, between those treated with fluoxetine versus placebo? 5. Is there a difference in cognition, at 6 months and 12 months after stroke, between those patients treated with fluoxetine versus placebo? 6. Is there a difference in aspects of quality of life (mood, fatigue, participation) at 6 and 12 months between those treated with fluoxetine versus placebo? 7. Is there a difference in the cost of health and social care over at 6 months and 12 months between those treated with fluoxetine versus placebo? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Survival to one year and beyond • Euroquol 5D to provide overall assessment of the patients health related Quality of life. • MHI 5- the mental health inventory from the SF36 will provide a measure of depression and anxiety. This brief measure performs well, compared with longer questionnaires (e.g. MHI-18, GHQ-12, GHQ-30, in the detection of depression and anxiety (Berwick et la 1991, Mccabe et al 1996, Hoeymans at al 2004) • The vitality subscale of the SF36 will be used to assess patients level of fatigue • The Stroke Impact Scale will provide an overall assessment of patient outcome as well as allowing us to assess the effect of treatment on specific outcomes of importance to the patients. • New diagnosis of depression since randomisation requiring antidepressant medication • Hospitalisation days since enrolment. (obtained from GPs or if not randomising centre) • Days spent in care home since randomisation • Formal carers – total number of visits per week;Timepoint(s) of evaluation of this end point: Adverse effects will be reported at hospital discharge. All endpoints including adverse effects will be collected at 6 months after randomisation. All endpoints will be collected at 12 months after randomisation. Additionally, there will be a 24 hour helpline, a participant section of the trial website where advice on possible adverse events can be collated, and participants will be given a freepost envelope and card to return to us with details of any adverse reactions that they have experienced | — |
Countries
United Kingdom
Outcome results
None listed