Establishing the effect(s) and safety of Fluoxetine initiated in the acute phase of stroke
- Conditions
- Ischaemic or haemorrhagic strokeCirculatory System
- Registration Number
- ISRCTN13020412
- Lead Sponsor
- Karolinska Institute (Karolinska Institutet)
- Brief Summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26289352 2017 statistical and health economic analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/29282099 2020 update to protocol in https://www.ncbi.nlm.nih.gov/pubmed/32111264 (added 02/03/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32702335/ (added 27/07/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1500
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Rankin scale at 6 months
- Secondary Outcome Measures
Name Time Method