ESTABLISHING THE EFFECT(S) AND SAFETY OF FLUOXETINE IN NON-DEPRESSED STROKE PATIENTS INITIATED IN THE ACUTE PHASE OF STROKE

• Conditions: Cerebrovascular diseases; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-006130-16-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-16
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1550

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range 1250

Exclusion Criteria

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.
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
a) 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 inhibitors 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the routine administration of Fluoxetine (20mg od) for 6 months after an acute stroke improve patients’ functional outcome?;Secondary Objective: Does the routine administration of Fluoxetine (20mg od) for 6 months after an acute stroke:<br>1. Improve patients’ motor function and does any improvement persist?<br>2. Improve patients’ communication function and does any improvement persist?<br>3. Improve patients’ outcome with respect to mood, fatigue, cognition, health related quality of<br>life or participation in an active life and does any improvement persist?<br>4. Reduce the cost of health and social care over the first year?<br>5.Increase the risk of serious adverse events?<br>;Primary end point(s): Modified Rankin Scale, ordinal analysis;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Survival at 6 & 12 months; Stroke Impact Scale; EQ5D-5L; MHI 5; Vitality subscale of the Heath Questionnaire, and cardio-vascular morbidity; DSM-diagnosis of depression; Adherence to medication; Adverse events; Resource use; and Investigations: NIHSS (motor function); one part of NGTA (comprehension, yes/no), MoCA (cognition), DSM-IV, and MADRS (if feasible) (mood), CGI frequency (emotionalism).;Timepoint(s) of evaluation of this end point: 6 and 12 months