Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke

Karolinska Institute (Karolinska Institutet)0 个研究点目标入组 1,500 人开始时间: 2014年12月19日最近更新: 2020年8月10日

适应症

试验速览

•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

•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

发起方