StrokePhase 2FLOWNCT03448159
Fluoxetine Opens Window to Improve Motor Recovery After Stroke
A Phase 2 study testing Fluoxetine Hydrochloride and Exercise Program in people with Stroke and Cerebrovascular Accident, run by University Health Network, Toronto at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Cerebral Infarction
- What is being tested?
- Fluoxetine Hydrochloride and Exercise Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Jan 2019to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
University of Calgary
Calgary, Alberta, T2N 2T9
Dalhousie University
Halifax, Nova Scotia, B3H 3J5
Parkwood Institute
London, Ontario, N6C 0A7
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1A 1E5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2
University of British Columbia & GF Strong Centre
Vancouver, British Columbia, V5Z 2G9
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
About this study
Official title: FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke
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.
Read the 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 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.
- Conditions
- Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders
- Being tested
- Fluoxetine Hydrochloride, Placebo, Exercise Program
- Keywords
- Stroke, Exercise, Fluoxetine, Randomized Control Trial, Rehabilitation
- Medical subject headings
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine HydrochlorideDrug
Also called Prozac
Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
PlaceboOther
Also called "Sugar" Pill
Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
Exercise ProgramBehavioural
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine Hydrochloride | Experimental | 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). Receives: Drug: Fluoxetine Hydrochloride; Behavioral: Exercise Program |
| Placebo | Placebo comparator | 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). Receives: Other: Placebo; Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following completion of the 12-week exercise intervention
Secondary outcomes (14)
6 Minute Walk Test / 10 Meter Walk Test
Physical Measurement - Ambulatory Function
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Knee Strength
Physical Measurement- Lower Limb Strength
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Berg Balance Assessment
Physical Measurement - Balance Function
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Grip Strength
Physical Measurement - Grip Strength
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Waist-to-Hip Ratio
Physical Measurement - Health Measurement
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Body Mass Index
Physical Measurement - Health Measurement
Measured: 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.
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fugl-Meyer Lower Extremity Score
Impairment Measurement (see description above)
Measured: 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.
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Patient Health Questionnaire (PHQ)-9
Depression Measurement
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Simple and Choice Reaction Time Test
Cognitive Measurement
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Trail Making Test - A & B
Cognitive Measurement
Measured: 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
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fasting Blood Draws
Biological Biomarker
Measured: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Sunnybrook Health Sciences Centre, University of Calgary, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, Memorial University of Newfoundland, Applied Health Research Centre, Brain Canada, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Mark Bayley, MD, Principal investigator, University Health Network, TorontoCourtney Pollock, PhD, Principal investigator, University of British Columbia & GF Strong Rehab CentreBradley MacIntosh, PhD, Principal investigator, Sunnybrook Health Sciences CentreSean Dukelow, MD, Principal investigator, University of CalgarySepideh Pooyania, MD, Principal investigator, Riverview Health CentreMichelle Ploughman, PhD, Principal investigator, Memorial University of NewfoundlandMarilyn Mackay-Lyons, PhD, Principal investigator, Dalhousie UniversityRobert Teasell, MD, Principal investigator, Parkwood Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448159
- Sponsor's protocol ID
- 18-6002
- Other IDs
- CTO #1465
- Acronym
- FLOW
- Status last verified
- Nov 2022
- First submitted
- 21 Feb 2018
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Alexander LD, Black SE, Patterson KK, Gao F, Danells CJ, McIlroy WE. Association between gait asymmetry and brain lesion location in stroke patients. Stroke. 2009 Feb;40(2):537-44. doi: 10.1161/STROKEAHA.108.527374. Epub 2008 Dec 24.
PubMed 19109546AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.
PubMed 25892679Salbach NM, Wood-Dauphinee S, Desrosiers J, Eng JJ, Graham ID, Jaglal SB, Korner-Bitensky N, MacKay-Lyons M, Mayo NE, Richards CL, Teasell RW, Zwarenstein M, Bayley MT; Stroke Canada Optimization of Rehabilitation By Evidence - Implementation Trial (SCORE-IT) Team. Facilitated interprofessional implementation of a physical rehabilitation guideline for stroke in inpatient settings: process evaluation of a cluster randomized trial. Implement Sci. 2017 Aug 1;12(1):100. doi: 10.1186/s13012-017-0631-7.
PubMed 28764752Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctot KL. Kynurenine and depressive symptoms in a poststroke population. Neuropsychiatr Dis Treat. 2014 Sep 22;10:1827-35. doi: 10.2147/NDT.S65740. eCollection 2014.
PubMed 25285006Berends HI, Nijlant J, van Putten M, Movig KL, IJzerman MJ. Single dose of fluoxetine increases muscle activation in chronic stroke patients. Clin Neuropharmacol. 2009 Jan-Feb;32(1):1-5.
PubMed 19536922Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
PubMed 14762143Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875Bradbury EJ, Moon LD, Popat RJ, King VR, Bennett GS, Patel PN, Fawcett JW, McMahon SB. Chondroitinase ABC promotes functional recovery after spinal cord injury. Nature. 2002 Apr 11;416(6881):636-40. doi: 10.1038/416636a.
PubMed 11948352Breceda EY, Dromerick AW. Motor rehabilitation in stroke and traumatic brain injury: stimulating and intense. Curr Opin Neurol. 2013 Dec;26(6):595-601. doi: 10.1097/WCO.0000000000000024.
PubMed 24141528Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
PubMed 21216670Cumberland Consensus Working Group; Cheeran B, Cohen L, Dobkin B, Ford G, Greenwood R, Howard D, Husain M, Macleod M, Nudo R, Rothwell J, Rudd A, Teo J, Ward N, Wolf S. The future of restorative neurosciences in stroke: driving the translational research pipeline from basic science to rehabilitation of people after stroke. Neurorehabil Neural Repair. 2009 Feb;23(2):97-107. doi: 10.1177/1545968308326636.
PubMed 19189939Dhami KS, Churchward MA, Baker GB, Todd KG. Fluoxetine and citalopram decrease microglial release of glutamate and D-serine to promote cortical neuronal viability following ischemic insult. Mol Cell Neurosci. 2013 Sep;56:365-74. doi: 10.1016/j.mcn.2013.07.006. Epub 2013 Jul 19.
PubMed 23876875Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.
PubMed 25972803Espinera AR, Ogle ME, Gu X, Wei L. Citalopram enhances neurovascular regeneration and sensorimotor functional recovery after ischemic stroke in mice. Neuroscience. 2013 Sep 5;247:1-11. doi: 10.1016/j.neuroscience.2013.04.011. Epub 2013 Apr 13.
PubMed 23590907Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.
PubMed 25671798
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03448159
- Acronym / sponsor ID
- FLOW / 18-6002
- Conditions
- Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders
- Keywords
- Stroke, Exercise, Fluoxetine, Randomized Control Trial, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of British Columbia, Sunnybrook Health Sciences Centre, University of Calgary, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, Memorial University of Newfoundland, Applied Health Research Centre, Brain Canada, Heart and Stroke Foundation of Canada
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine Hydrochloride | Experimental | Drug: Fluoxetine Hydrochloride, Behavioral: Exercise ProgramFluoxetine (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). |
| Placebo | Placebo comparator | Other: Placebo, Behavioral: Exercise ProgramAn 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). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine HydrochlorideAlso: ProzacHalf of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period). | Drug | Fluoxetine Hydrochloride |
| PlaceboAlso: "Sugar" PillHalf of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period). | Other | Placebo |
| Exercise ProgramAll participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class. | Behavioural | Fluoxetine Hydrochloride, Placebo |
Primary outcome
Fugl-Meyer Lower Extremity Score
Time frame: Following completion of the 12-week exercise intervention
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.
14 secondary outcomes
6 Minute Walk Test / 10 Meter Walk Test
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Knee Strength
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Berg Balance Assessment
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Grip Strength
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Waist-to-Hip Ratio
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Body Mass Index
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Stroke Impact Scale
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fugl-Meyer Lower Extremity Score
Time frame: 6-months post-exercise intervention
Fugl-Meyer Upper Extremity Score
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Patient Health Questionnaire (PHQ)-9
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Simple and Choice Reaction Time Test
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Trail Making Test - A & B
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)
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Fasting Blood Draws
Time frame: Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 19109546Alexander LD, Black SE, Patterson KK, Gao F, Danells CJ, McIlroy WE. Association between gait asymmetry and brain lesion location in stroke patients. Stroke. 2009 Feb;40(2):537-44. doi: 10.1161/STROKEAHA.108.527374. Epub 2008 Dec 24.
- Background: PubMed 25892679AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16.
- Background: PubMed 28764752Salbach NM, Wood-Dauphinee S, Desrosiers J, Eng JJ, Graham ID, Jaglal SB, Korner-Bitensky N, MacKay-Lyons M, Mayo NE, Richards CL, Teasell RW, Zwarenstein M, Bayley MT; Stroke Canada Optimization of Rehabilitation By Evidence - Implementation Trial (SCORE-IT) Team. Facilitated interprofessional implementation of a physical rehabilitation guideline for stroke in inpatient settings: process evaluation of a cluster randomized trial. Implement Sci. 2017 Aug 1;12(1):100. doi: 10.1186/s13012-017-0631-7.
- Background: PubMed 25285006Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctot KL. Kynurenine and depressive symptoms in a poststroke population. Neuropsychiatr Dis Treat. 2014 Sep 22;10:1827-35. doi: 10.2147/NDT.S65740. eCollection 2014.
- Background: PubMed 19536922Berends HI, Nijlant J, van Putten M, Movig KL, IJzerman MJ. Single dose of fluoxetine increases muscle activation in chronic stroke patients. Clin Neuropharmacol. 2009 Jan-Feb;32(1):1-5.
- Background: PubMed 14762143Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
- Background: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Background: PubMed 11948352Bradbury EJ, Moon LD, Popat RJ, King VR, Bennett GS, Patel PN, Fawcett JW, McMahon SB. Chondroitinase ABC promotes functional recovery after spinal cord injury. Nature. 2002 Apr 11;416(6881):636-40. doi: 10.1038/416636a.
- Background: PubMed 24141528Breceda EY, Dromerick AW. Motor rehabilitation in stroke and traumatic brain injury: stimulating and intense. Curr Opin Neurol. 2013 Dec;26(6):595-601. doi: 10.1097/WCO.0000000000000024.
- Background: PubMed 21216670Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.
- Background: PubMed 19189939Cumberland Consensus Working Group; Cheeran B, Cohen L, Dobkin B, Ford G, Greenwood R, Howard D, Husain M, Macleod M, Nudo R, Rothwell J, Rudd A, Teo J, Ward N, Wolf S. The future of restorative neurosciences in stroke: driving the translational research pipeline from basic science to rehabilitation of people after stroke. Neurorehabil Neural Repair. 2009 Feb;23(2):97-107. doi: 10.1177/1545968308326636.
- Background: PubMed 23876875Dhami KS, Churchward MA, Baker GB, Todd KG. Fluoxetine and citalopram decrease microglial release of glutamate and D-serine to promote cortical neuronal viability following ischemic insult. Mol Cell Neurosci. 2013 Sep;56:365-74. doi: 10.1016/j.mcn.2013.07.006. Epub 2013 Jul 19.
- Research breakthrough to revolutionize stroke treatmentLink provided by the sponsor.
- Tracking Heart Disease and Stroke in CanadaLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Bayley, MD principal investigator
University Health Network, Toronto
Courtney Pollock, PhD principal investigator
University of British Columbia & GF Strong Rehab Centre
Bradley MacIntosh, PhD principal investigator
Sunnybrook Health Sciences Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine Hydrochloride and Exercise Program in people with Stroke and Cerebrovascular Accident, run by University Health Network, Toronto at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Lower Extremity Score (time frame: Following completion of the 12-week exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448159, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.