A Phase 2 interventional study of Fluoxetine Hydrochloride and Placebo in Stroke, Cerebrovascular Accident and Cerebral Infarction, sponsored by University Health Network, Toronto. Completed at 8 sites in Canada. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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).
Drug: Fluoxetine Hydrochloride · Behavioral: Exercise Program
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).
Other: Placebo · Behavioral: Exercise Program
Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
Also known as: Prozac
Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
Also known as: "Sugar" Pill
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
Fugl-Meyer Lower Extremity Score
Fugl-Meyer Lower Extremity Assessment assesses motor and sensorimotor impairment in the lower extremities. Total score is between 0 and 34. Sub-scales include: proximal (0-18), knee/ankle (0-10) and coordination/speed (0-6). Higher scores indicate better performance. Sub-scale scores are summed to calculate total score.
Time frame: Following completion of the 12-week exercise intervention
6 Minute Walk Test / 10 Meter Walk Test
Physical Measurement - Ambulatory Function
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Knee Strength
Physical Measurement- Lower Limb Strength
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Berg Balance Assessment
Physical Measurement - Balance Function
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Grip Strength
Physical Measurement - Grip Strength
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Waist-to-Hip Ratio
Physical Measurement - Health Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Body Mass Index
Physical Measurement - Health Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Stroke Impact Scale
Stroke-specific, self-report, health status measure. Assesses multiple domains on a 5-point Likert scale. Domains include: strength (4-20), hand function (5-25), activities of daily living/instrumental activities of daily living (10-50), mobility (9-45), communication (7-35), emotion (9-45), memory and thinking (7-35), and participation (8-40). An extra question asks that the patient rate on a scale from 0 - 100 how much they feel that he/she has recovered from his/her stroke. The 4 physical domains (strength, hand function, mobility and activities of daily living) can be summed together to create a single, physical dimension score (28-140) while all other domains should remain separate. Higher scores indicate better function.
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fugl-Meyer Lower Extremity Score
Impairment Measurement (see description above)
Time frame: 6-months post-exercise intervention
Fugl-Meyer Upper Extremity Score
Fugl-Meyer Upper Extremity Assessment assesses motor and sensorimotor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66), and sensation (0-4). Higher scores indicate better performance.
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Patient Health Questionnaire (PHQ)-9
Depression Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Simple and Choice Reaction Time Test
Cognitive Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Trail Making Test - A & B
Cognitive Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Montreal Cognitive Assessment (including 5 word recall and clock test)
Cognitive Measurement
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fasting Blood Draws
Biological Biomarker
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Plan to share: Undecided — Unused blood samples will be processed and centrally stored in cryovials in a minus 80 degrees freezer for future analyses under the supervision of Study Investigator, Dr. Sandra Black (Sunnybrook, M6 West, 2075 Bayview Avenue, Toronto). The intent is to make the stored frozen cryovials available to all Heart and Stroke Foundation Canadian Partnership of Stroke Recovery (CPSR) investigators to apply for access, but it is currently undecided if other researchers will be allowed to apply for access to the samples. Access will be controlled by a Subcommittee of CPSR Investigators who will review and approve requests and oversee access to the biobank. Stored cryovials will remain at Sunnybrook under the supervision of Dr. Sandra Black for a period of up to 10 years.
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University Health Network, Toronto