Fluoxetine Opens Window to Improve Motor Recovery After Stroke

(FLOW Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Michelle Ploughman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marilyn Mackay-Lyons, PhD

Principal Investigator

Dalhousie University

Robert Teasell, MD

Principal Investigator

Parkwood Institute

Mark Bayley, MD

Principal Investigator

University Health Network, Toronto

Courtney Pollock, PhD

Principal Investigator

University of British Columbia & GF Strong Rehab Centre

Bradley MacIntosh, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Sean Dukelow, MD

Principal Investigator

University of Calgary

Sepideh Pooyania, MD

Principal Investigator

Riverview Health Centre

Michelle Ploughman, PhD

Principal Investigator

Memorial University of Newfoundland

Eligibility Criteria

Inclusion Criteria

25 years of age or older

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

Patient-reported hemiparesis of the lower extremity

Treatment Details

Interventions

• Exercise Program (Behavioural Intervention)
• Fluoxetine Hydrochloride (Selective Serotonin Reuptake Inhibitor)
• Placebo (Other)

Participant Groups

Group I: Fluoxetine Hydrochloride Experimental Treatment 2 Interventions

Fluoxetine (Prozac) will be administered to this group. A ramp up period of 3-5 weeks will take place where the patient takes 10mg of Prozac per day. After that, the participant will take the regular dose of 20mg for the duration of the exercise intervention (12 weeks).

Group II: Placebo Placebo Group 2 Interventions

An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. During the 3-5 week ramp up period for the experimental group, these participants will take a placebo identical to the 10mg Prozac capsule. After that, the participant will take a placebo identical to the 20mg Prozac capsule for the duration of the exercise intervention (12 weeks).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Riverview Health Centre Winnipeg, Canada

Memorial University of Newfoundland St. John's, Canada

University of British Columbia & GF Strong Centre Vancouver, Canada

Dalhousie University Halifax, Canada

More Trial Locations

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1555

Patients Recruited

526,000+

Dalhousie University

Collaborator

Trials

177

Patients Recruited

402,000+

Applied Health Research Centre

Collaborator

Trials

23

Patients Recruited

70,900+

Parkwood Hospital, London, Ontario

Collaborator

Trials

8

Patients Recruited

790+

University of British Columbia

Collaborator

Trials

1506

Patients Recruited

2,528,000+

University of Calgary

Collaborator

Trials

827

Patients Recruited

902,000+

Riverview Health Centre Foundation

Collaborator

Trials

6

Patients Recruited

340+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Patients Recruited

1,569,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Patients Recruited

1,836,000+

Brain Canada

Collaborator

Trials

22

Patients Recruited

6,100+