Ischaemic or haemorrhagic stroke Circulatory System
Conditions
Interventions
Fluoxetine 20mg once daily or matching placebo capsules for 6 months
Sponsors
Karolinska Institute (Karolinska Institutet)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 2. Informed consent can only be obtained from a patient who according to the trial investigator is mentally capable of decision-making and who, after having received information and got answers to their questions, wants to participate in the trial 3. Brain imaging is compatible with intra cerebral hemorrhage or ischaemic stroke 4. Randomization can be performed between 2 and 15 days after stroke onset and by the research group at the patient’s local/emergency hospital 5. Persisting focal neurological deficit is present at the time of randomization severe enough to warrant treatment from the physicians and the patient’s and relative’s perspective
Exclusion criteria
Exclusion criteria: 1. Subarachnoidal hemorrhage (except where secondary to a primary intracerebral hemorrhage) 2. Unlikely to be available for follow up for the next 12 months e.g. no fixed home address 3. Unable to speak Swedish and no close family member available to help with follow up forms 4. Other life threatening illness (e.g. advanced cancer) that will make 12-month survival unlikely 5. History of epileptic seizures 6. History of allergy or contraindications to fluoxetine including: 6.1. Hepatic impairment (S-ASAT/ALAT > 3 upper normal limit) 6.2. Renal impairment (S-Creatinine levels > 180 micromol/L) 7. Pregnant or breastfeeding, women of childbearing age not taking contraception. Minimum contraception is an oral contraceptive. An HCG-test is to be made prior randomization and after the end of trial medication 8. Previous drug overdose or attempted suicide 9. Already enrolled into a CTIMP 10. Current or recent (within the last month) depression requiring treatment with an SSRI antidepressant 11. Current use of medications which have serious interactions with fluoxetine 11.1. Use of any mono-amino-oxidase inhibitor (MAOI) during the last 5 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin scale at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deaths from all causes by 6 and 12 months. Death from all causes until the end of the trial ascertained via the medical record system at the local centres which is linked to National Registry (Folkbokföringsregistret) (local follow up) 2. The EuroQoL (EQ5D-5L) to provide an overall measure of health related quality of life (HRQOL) and to allow a health economic analysis based on quality adjusted life years 3. The mental health inventory 5 (MHI 5) 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 4. The vitality subscale of the Health Questionnaire, equivalent to SF 36, will be used to assess patients level of fatigue 5. The Stroke Impact Scale (SIS) 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 SIS is a stroke-specific, comprehensive, health status measure. The 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 (Duncan 1999; 2003). It also provided an overall assessment of recovery. The scale has been evaluated successfully for use by proxy respondents and has been delivered as both telephone and postal questionnaires 6. New diagnosis of depression since randomization. We will record whether a depression has been treated by the PI; or resulted in a referral for specialist assessment and whether the diagnosis was confirmed by a psychiatrist and whether antidepressant medication was initiated; whether there was any attempt at suicide or self-harm. We will also, prior to dispensation of the study-medication for the second three-mo | — |
Countries
Sweden
Outcome results
None listed