NCT03448159

Fluoxetine Opens Window to Improve Motor Recovery After Stroke

FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Stroke
• Cerebrovascular Accident
• Cerebral Infarction
• Brain Infarction
• Brain Ischemia
• Cerebrovascular Disorders
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases
• Vascular Diseases

Interventions

Type	Name	Description
DRUG	Fluoxetine Hydrochloride	Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
OTHER	Placebo	Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
BEHAVIORAL	Exercise Program	All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2018-02-27
• Last updated: 2022-11-04

Locations

8 sites across 1 country: Canada