Fluoxetine Opens Window to Improve Motor Recovery After Stroke

University Health Network, Toronto52 enrolled

Overview

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.

FLOW Trial is a randomized, placebo-controlled, blinded phase II trial evaluating the efficacy of coupling antidepressant therapy (e.g., selective serotonin reuptake inhibitor - fluoxetine) with exercise rehabilitation across multiple Canadian sites in 176 stroke patients. 88 patients will be enrolled in each arm of the study. Both groups will receive an exercise program in addition to standard of care rehabilitation, but only one group (the intervention group) will receive the active drug fluoxetine. Study participants will be evaluated at baseline, post-exercise program and 6-months post-exercise program. While enrolled in the study, participants will be required to take part in a 12 week, 3 times per week exercise program. Evaluators and patients will be blind to the treatment administered. The trial is constructed with randomization to remove selection and allocation biases and to ensure greater validity in observed differences in the outcome measures. The Applied Health Research Centre (AHRC) in Toronto will act as the coordinating and analysis center.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke Cerebrovascular Accident

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Calgary

Calgary, Alberta, Canada

University of British Columbia & GF Strong Centre

Vancouver, British Columbia, Canada

Riverview Health Centre

Winnipeg, Manitoba, Canada

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Parkwood Institute

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Fugl-Meyer Lower Extremity Score

Fugl-Meyer Lower Extremity Assessment assesses motor and sensorimotor impairment in the lower extremities. Total score is between 0 and 34. Sub-scales include: proximal (0-18), knee/ankle (0-10) and coordination/speed (0-6). Higher scores indicate better performance. Sub-scale scores are summed to calculate total score.

Time frame: Following completion of the 12-week exercise intervention