Efficacy of Fluoxetine - a Trial in Stroke "EFFECTS"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- 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.
- Brain imaging is compatible with intra cerebral hemorrhage or ischemic stroke.
- Randomization can be performed between 2 and 15 days after stroke onset and by the research group at the patient's local/emergency hospital.
- 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.

Exclusion Criteria

- Subarachnoidal hemorrhage except where secondary to a primary intracerebral hemorrhage.
- Unlikely to be available for follow up for the next 12 months e.g. no fixed home address.
- Unable to speak Swedish and no close family member available to help with follow up forms.
- Other life threatening illness (e.g. advanced cancer) that will make 12-month survival unlikely.
- History of epileptic seizures.
- History of allergy or contraindications to fluoxetine including: Hepatic impairment (S-ASAT/ALAT > 3 upper normal limit) and renal impairment (S-Creatinine levels > 180 micromol/L).
- 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.
- Previous drug overdose or attempted suicide.
- Already enrolled into a CTIMP.
- Current or recent (within the last month) depression requiring treatment with an SSRI antidepressant.
Current use of medications which have serious interactions with fluoxetine Use of any mono-amino-oxidase inhibitor (MAOI) during the last 5 weeks. Co-administration of Fluoxetine and a mono-amino-oxidase inhibitor (MAOI) may result in life threatening interactions. Therefore, patients on MAOI are ineligible for the EFFECTS trial. Also, any patient in need of treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI, or to be treated as in-patients by a psychiatrist.