Fluoxetine Opens Window to Improve Motor Recovery After Stroke

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The FLOW trial is a randomized placebo-controlled trial analyzing the effect of coupling an anti-depressant, fluoxetine (Prozac), and exercise to improve motor recovery following a stroke.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Applied Health Research Centre; Brain Canada; Dalhousie University; Heart and Stroke Foundation Canadian Partnership for Stroke Recovery; Memorial University of Newfoundland; Parkwood Hospital, London, Ontario; Riverview Health Centre Foundation; Sunnybrook Health Sciences Centre; University of British Columbia; University of Calgary; University of Waterloo
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

1. 25 years of age or older

2. Days post stroke must be between 2 to 12 months when enrolled (i.e. day of consent)

3. Patient-reported hemiparesis of the lower extremity

Exclusion Criteria:

1. Patients with subarachnoid hemorrhage

2. Pre-morbid modified Rankin score > 2

3. Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments

4. Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment

5. Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment

6. Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)

7. Resting blood pressure exceeding 180/100mmHg

8. Requires more than a one person assist for transfer

9. Planned surgery that would affect participation in the trial

10. Participating in another formal lower limbs exercise program more than one day per week

11. History of QT prolongation or concomitant use of clearly identified potential QT prolonging drugs, at the investigators discretion (e.g. amiodarone, bepridil, dysopyramide, dofetilide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol, phenothiazines, pimozide, ziprasidone, TCAs, halofantrine, cisapride, and probucol)

12. History of glaucoma

13. Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion

14. History of convulsive disorders

15. Potential pregnancy (per screening algorithm)

16. Patients with an ongoing history of illicit drug use and/or alcohol abuse

17. Patient unwilling or unable to comply with trial requirements

18. Patient unable to understand English or communicate with the study team with staff support or translation services