None listed
Conditions
Brief summary
Does routine administration of fluoxetine (20mg od) in the 6 months after acute stroke improve patients’ functional outcome?
Interventions
Fluoxetine (20mg once daily) for 6 months via oral capsule or enteral tube.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Men or women aged 18 years or more with: - Clinical diagnosis of stroke 2-15 days previously (Day of stroke onset = Day 0, randomise on Day 2-15); - Brain imaging consistent with ischaemic or haemorrhagic (intracerebral and/or subarachnoid) stroke (including normal CT brain scan); - Persisting measurable focal neurological deficits (e.g. motor, somatosensory, visual, language, cognitive) present at randomisation and severe enough to produce a modified Rankin Scale (mRS) score of equal or > 1 and to warrant treatment from the perspective of patient or carer(s).
Exclusion criteria
Exclusion Criteria Any of the following: History of epileptic seizures History of bipolar disorder History of drug overdose or attempted suicide Ongoing treatment with any selective serotonin reuptake inhibitor (SSRI) Allergy or contra indication to fluoxetine including Hepatic impairment (serum alanine aminotransferase [ALT] >120 U/l), Renal impairment (creatinine >180micromol/l or eGFR < 30ml/min/1.73m2), Hyponatremia (sodium <125mmol/L) despite treatment of the cause and confirmed on repeat testing, Use of medications that may interact seriously with fluoxetine Proposed use of a monoamine oxidase inhibitor (MAOI), or use of a MAOI within 14 days prior to randomisation Current treatment with an antipsychotic drug (neuroleptic), pimozide, tamoxifen, or tramadol, unless the patient, doctor and if possible prescribing doctor, believe it is appropriate to discontinue use. Not available for follow up over the next 365 days e.g. no fixed home address. Life-threatening illness (e.g. advanced cancer) that is likely to reduce 365 day survival Pregnant, breast-feeding or of child-bearing potential and not using contraception Enrolled in another interventional clinical research trial involving an investigational product (medicine) or device
Outcome results
None listed