Fluoxetine Opens Window to Improve Motor Recovery After Stroke

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Parkwood Hospital, London, Ontario

  collaborator OTHER

• Riverview Health Centre Foundation

  collaborator OTHER

• Memorial University of Newfoundland

  collaborator OTHER

• Applied Health Research Centre

  collaborator OTHER

• Brain Canada

  collaborator OTHER

• Heart and Stroke Foundation Canadian Partnership for Stroke Recovery

  collaborator UNKNOWN

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Mark Bayley, MD · University Health Network, Toronto

• Courtney Pollock, PhD · University of British Columbia & GF Strong Rehab Centre

• Bradley MacIntosh, PhD · Sunnybrook Health Sciences Centre

• Sean Dukelow, MD · University of Calgary

• Sepideh Pooyania, MD · Riverview Health Centre

• Michelle Ploughman, PhD · Memorial University of Newfoundland

• Marilyn Mackay-Lyons, PhD · Dalhousie University

• Robert Teasell, MD · Parkwood Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Canada

Study Locations