Fluoxetine Opens Window to Improve Motor Recovery After Stroke
NCT ID: NCT03448159
Last Updated: 2022-11-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
52 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-01
Study Completion Date
2022-09-30
Brief Summary
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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.
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Detailed Description
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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 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
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Stroke
Cerebrovascular Accident
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 intervention
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Fluoxetine Hydrochloride
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 Type
EXPERIMENTAL
Fluoxetine Hydrochloride
Intervention Type
DRUG
Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
Exercise Program
Intervention Type
BEHAVIORAL
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
Placebo
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).
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
Exercise Program
Intervention Type
BEHAVIORAL
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
Interventions
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Fluoxetine Hydrochloride
Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
Intervention Type
DRUG
Placebo
Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
Intervention Type
OTHER
Exercise Program
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Prozac
"Sugar" Pill
Eligibility Criteria
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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
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
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
Minimum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of British Columbia
OTHER
Sponsor Role
collaborator
Sunnybrook Health Sciences Centre
OTHER
Sponsor Role
collaborator
University of Calgary
OTHER
Sponsor Role
collaborator
Dalhousie University
OTHER
Sponsor Role
collaborator
Parkwood Hospital, London, Ontario
OTHER
Sponsor Role
collaborator
Riverview Health Centre Foundation
OTHER
Sponsor Role
collaborator
Memorial University of Newfoundland
OTHER
Sponsor Role
collaborator
Applied Health Research Centre
OTHER
Sponsor Role
collaborator
Brain Canada
OTHER
Sponsor Role
collaborator
Heart and Stroke Foundation Canadian Partnership for Stroke Recovery
UNKNOWN
Sponsor Role
collaborator
University Health Network, Toronto
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mark Bayley, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Courtney Pollock, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia & GF Strong Rehab Centre
Bradley MacIntosh, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Sean Dukelow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Sepideh Pooyania, MD
Role: PRINCIPAL_INVESTIGATOR
Riverview Health Centre
Michelle Ploughman, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial University of Newfoundland
Marilyn Mackay-Lyons, PhD
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Robert Teasell, MD
Role: PRINCIPAL_INVESTIGATOR
Parkwood Institute
Locations
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University of Calgary
Calgary, Alberta, Canada
Site Status
University of British Columbia & GF Strong Centre
Vancouver, British Columbia, Canada
Site Status
Riverview Health Centre
Winnipeg, Manitoba, Canada
Site Status
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
Site Status
Dalhousie University
Halifax, Nova Scotia, Canada
Site Status
Parkwood Institute
London, Ontario, Canada
Site Status
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Site Status
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, Canada
Site Status
Countries
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Canada
References
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BACKGROUND
Zittel S, Weiller C, Liepert J. Citalopram improves dexterity in chronic stroke patients. Neurorehabil Neural Repair. 2008 May-Jun;22(3):311-4. doi: 10.1177/1545968307312173. Epub 2008 Jan 24.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.heartandstroke.ca/articles/research-breakthrough-to-revolutionize-stroke-treatment
Research breakthrough to revolutionize stroke treatment
http://www.phac-aspc.gc.ca/publicat/2009/cvd-avc/pdf/cvd-avs-2009-eng.pdf
Tracking Heart Disease and Stroke in Canada
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTO #1465
Identifier Type: OTHER
Identifier Source: secondary_id
18-6002
Identifier Type: -
Identifier Source: org_study_id
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