Fluoxetine Opens Window to Improve Motor Recovery After Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Diseases
- Brain Infarction
- Brain Ischemia
- Central Nervous System Diseases
- Cerebral Infarction
- Cerebrovascular Accident
- Cerebrovascular Disorders
- Nervous System Diseases
- Stroke
- Vascular Diseases
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm 1: Intervention group (will receive the trial drug, fluoxetine, as well as an exercise intervention) Arm 2: Placebo group (will receive a placebo as well as an exercise interventionMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 125 years
- Gender
- Both males and females
Description
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 enroll...
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.
Tracking Information
- NCT #
- NCT03448159
- Collaborators
- University of British Columbia
- Sunnybrook Health Sciences Centre
- University of Calgary
- Dalhousie University
- Parkwood Hospital, London, Ontario
- Riverview Health Centre Foundation
- Memorial University of Newfoundland
- Applied Health Research Centre
- Brain Canada
- Heart and Stroke Foundation Canadian Partnership for Stroke Recovery
- Investigators
- Principal Investigator: Mark Bayley, MD University Health Network, Toronto Principal Investigator: Courtney Pollock, PhD University of British Columbia & GF Strong Rehab Centre Principal Investigator: Bradley MacIntosh, PhD Sunnybrook Health Sciences Centre Principal Investigator: Sean Dukelow, MD University of Calgary Principal Investigator: Sepideh Pooyania, MD Riverview Health Centre Principal Investigator: Michelle Ploughman, PhD Memorial University of Newfoundland Principal Investigator: Marilyn Mackay-Lyons, PhD Dalhousie University Principal Investigator: Robert Teasell, MD Parkwood Institute
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