Survival
Survival will be analysed with the Cox proportional hazards model adjusting for the factors included in the minimisation algorithm
Functional status, measured with the modified Rankin scale.
The simple modified Rankin scale questionnaire delivered by postal questionnaire, or via interview over the telephone or face to face to determine the modified Rankin scale. The study will also investigate if the benefits of Fluoxetine remains at 12 months.
Health status measured with the Stroke Impact Scale
Health status will be measured with the Stroke Impact Scale
Arm, hand, leg and foot strength assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
The 8 domains in the Stroke Impact Scale will be used for secondary outcome measures 5 to 13.
Hand function assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Mobility assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Communication and understanding assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Memory and thinking assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Mood and emotions assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Daily activities assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Participation in work, leisure and social activities assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Overall rating of recovery assessed with the Stroke Impact Scale
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. The Stroke Impact Scale was developed with input from both patients and caregivers and includes 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, participation) from across the full impairment-participation continuum.
Adverse events/outcomes
We will specifically ask for adverse events at each follow-up time (1 week, 1 month, 3 months, 6 months and 12 months), see the outcome 16-24 below. The definition of the SAE is defined according to Good Clinical Practice. We will not register known side effects of fluoxetine, which are listed in the drug's Summary of Product Characteristics. We will not register known problems following stroke, such as pneumonia, deep vein thrombosis etc.
Depression using the Montgomery-Åsberg Depression Rating Scale (MADRS)
Depression using the Montgomery-Åsberg Depression Rating Scale (MADRS) and patients scoring high have a diagnosis of depression confirmed based on the DSM-IV criteria.
Number of participants with a recurrent stroke including ischaemic and hemorrhagic strokes
Number of participants with a recurrent stroke including ischaemic and hemorrhagic strokes
Number of participants with an acute coronary syndromes
Number of participants with an acute coronary syndromes
Number of participants with an Epileptic seizures
Number of participants with an epileptic seizures
Number of participants with an episodes of Hyponatraemia
Number of participants with an episodes of hyponatraemia (<125 mmol/l)
Number of participants with an upper gastrointestinal bleeding
Number of participants with an upper gastrointestinal bleeding
Number of participants with other major bleeds
Number of participants with an other major bleeds includes lower GI, extracranial, intracranial but extracerebral
Number of participants with poorly controlled diabetes
Number of participants with an poorly controlled diabetes including hyperglycaemia (>22 mmol/l) and hypoglycaemia
Number of participants with falls resulting in injury
Number of participants with falls resulting in injury
Number of participants with new fractures
Number of participants with new fractures
Fatigue measured with the vitality subscale of the Health Questionnaire
Fatigue will be measured with the vitality subscale of the Health Questionnaire, equivalent to SF 36.
Cognition assessed with the Stroke Impact Scale
Cognition-the Stroke Impact Scale, which incorporates an assessment of memory and thinking, is used in conjunction with with the Montreal Cognitive Assessment (MoCA)
Health-related quality of life measured with the five-level Euroqol 5D (EQ5D-5 L)
Health-related quality of life measured with the five-level Euroqol 5D (EQ5D-5 L).
Cost-effectiveness and cost-utility assessed by measuring costs, survival and health related quality of life (EQ5D)
Direct and indirect costs will be estimated at 3-month, 6- month and 1 year. Effects will be measured using survival and EuroQoL 5 Dimensions (EQ5D) scale, which will be estimated into a utility score. The effectiveness measure that will be used for comparison purposes, the quality adjusted life years (QALYs), will be estimated by multiplying the relevant time parameter of the comparison with the estimated utility scores.
A societal perspective will be adapted for the analysis, and comparison of costs and effects (QALYs) will be conducted for the period of the clinical trial, as well as by adopting a lifetime perspective, where costs and QALYs will be extrapolated beyond the duration of the trial over the expected lifetime of patients. Standard statistical regressions will be used in order to calculate the expected lifetime costs and QALYs.
Physical activity
Physical activity will be measured using the Saltin-Grimby Physical Activity Level Scale