Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke

Karolinska Institute (Karolinska Institutet)0 sites1,500 target enrollmentDecember 19, 2014

Overview

Registry

who.int

Start Date

December 19, 2014

End Date

October 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•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