ESTABLISHING THE EFFECT(S) AND SAFETY OF FLUOXETINE INITIATED IN THE ACUTE PHASE OF STROKE

Karolinska Institutet0 个研究点目标入组 1,550 人2014年6月16日

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注册库

who.int

开始日期

2014年6月16日

结束日期

待定

最后更新

11年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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 haemorrhage or ischaemic stroke
•4\. Randomisation 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 randomisation severe enough to warrant treatment from the physicians and the patient’s and relative’s perspective.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 300
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Subarachnoid haemorrhage (except where secondary to a primary intracerebral haemorrhage).
•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:
•a) Hepatic impairment (S\-ASAT/ALAT \> 3 upper normal limit)
•b) 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 randomisation and after the end of trial medication
•8\. Previous drug overdose or attempted suicide.