An Australasian, investigator-driven, NHMRC funded, multicentre, prospective randomised, parallel group, double-blind, placebo-controlled trial to establish the effect(s) of routine administration of fluoxetine (20mg once daily) in patients with recent stroke.

Sir Charles Gairdner Hospital0 个研究点目标入组 1,280 人开始时间: 2011年7月22日最近更新: 2021年2月22日

适应症

试验速览

暂无简介。

•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
•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

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