Status:
COMPLETED
Fluoxetine Opens Window to Improve Motor Recovery After Stroke
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
University of British Columbia
Sunnybrook Health Sciences Centre
Conditions:
Stroke
Cerebrovascular Accident
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief 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 exerc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with subarachnoid hemorrhage
- Pre-morbid modified Rankin score \> 2
- Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
- Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment
- Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment
- Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
- Resting blood pressure exceeding 180/100mmHg
- Requires more than a one person assist for transfer
- Planned surgery that would affect participation in the trial
- Participating in another formal lower limbs exercise program more than one day per week
- 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)
- History of glaucoma
- Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion
- History of convulsive disorders
- Potential pregnancy (per screening algorithm)
- Patients with an ongoing history of illicit drug use and/or alcohol abuse
- Patient unwilling or unable to comply with trial requirements
- Patient unable to understand English or communicate with the study team with staff support or translation services
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03448159
Start Date
January 1 2019
End Date
September 30 2022
Last Update
November 4 2022
Active Locations (8)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
University of British Columbia & GF Strong Centre
Vancouver, British Columbia, Canada, V5Z 2G9
3
Riverview Health Centre
Winnipeg, Manitoba, Canada, R3L 2P4
4
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1A 1E5