Leibovitch 2018.

Trial name or title	FLuoxetine Opens Window to improve motor recovery after stroke (FLOW)
Methods	Study type: interventional (clinical trial) Estimated enrolment: 176 participants Allocation: randomised Intervention model: parallel assignment Intervention model description Intervention group (trial drug (fluoxetine) and exercise intervention) Placebo group (placebo and exercise intervention) Masking: quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: treatment
Participants	Country: Canada Setting: inpatient Inclusion criteria: Age > 25 years Between 60 to 210 days post‐stroke at enrolment Lower limb FMMS < 30 Exclusion criteria: Subarachnoid haemorrhage Pre‐morbid mRS > 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, MAOIs within 30 days of enrolment Unstable serious medical condition (e.g. terminal cancer, renal or liver failure, congestive heart failure) Resting blood pressure exceeding 180/100 mmHg Requires more than a one‐person assist for transfer Planned surgery that would affect participation in the trial Participating in another exercise programme more than 1 day a week Pregnant Ongoing history of illicit drug use or alcohol abuse or both Unwilling or unable to comply with trial requirements Unable to understand English
Interventions	Experimental: fluoxetine hydrochloride (Prozac): 10 mg Prozac per day for 3 to 5 weeks and then 20 mg for 12 weeks (the duration of the exercise intervention) Comparator: an over‐encapsulated placebo (identical 'sugar pill'): 10 mg 'sugar pill' a day for 3 to 5 weeks and then 20 mg for 12 weeks (the duration of the exercise intervention)
Outcomes	Primary outcomes at 12 weeks Fugl‐Meyer Lower Extremity Score at 12 weeks Secondary outcomes at 12 weeks and 6 months Ambulatory function measured using 6 Minute Walk Test/10 Metre Walk Test Lower limb strength measured using knee strength Balance measured using Berg Balance Assessment Grip Strength Waist‐to‐Hip Ratio Body Mass Index SIS Fugl‐Meyer Lower Extremity Score at 6 months Fugl‐Meyer Upper Extremity Score PHQ‐9 Simple and Choice Reaction Time Test Trail Making Test ‐ A & B Montreal Cognitive Assessment Fasting Blood Draws
Starting date	1 November 2018
Contact information	Farrell Leibovitch farrell@canadianstroke.ca
Notes	NCT03448159