Efficacy of Fluoxetine - a Trial in Stroke

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether routine administration of fluoxetine 20mg once daily in the 6 months initiated during the acute stroke improves the patient's functional outcome.

EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.

EFFECTS managed to recruit its anticipated numbers of 1,500 participants between 20th October 2014 and 28th June 2019. Data will be unblinded when the 6-months follow-up is completed, and the primary outcome is due to report on May 2020.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborators: Hjärnfonden (The Swedish Brain foundation); Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse; Stroke-Riksförbundet; Swedish Heart Lung Foundation; The Swedish Medical Association; The Swedish Research Council
• Treatments: Fluoxetine

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.