Fluoxetine Opens Window to Improve Motor Recovery After Stroke

NCT03448159 | Completed Phase 2 DMC

• 2 other identifiers: 18-6002CTO #1465
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

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.

Conditions

Stroke; Cerebrovascular Accident; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Keywords

Stroke; Exercise; Fluoxetine; Randomized Control Trial; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Following completion of the 12-week exercise intervention

Secondary Outcomes (14)

• 6 Minute Walk Test / 10 Meter Walk Test

  Following completion of the 12-week exercise intervention and 6-months post-exercise intervention

• Knee Strength

  Following completion of the 12-week exercise intervention and 6-months post-exercise intervention

• Berg Balance Assessment

  Following completion of the 12-week exercise intervention and 6-months post-exercise intervention

• Grip Strength

  Following completion of the 12-week exercise intervention and 6-months post-exercise intervention

• Waist-to-Hip Ratio

  Following completion of the 12-week exercise intervention and 6-months post-exercise intervention

Study Arms (2)

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).

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).

Other: Placebo; Behavioral: Exercise Program

Interventions

Fluoxetine Hydrochloride DRUG

Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).

Also known as: Prozac

Fluoxetine Hydrochloride

Placebo OTHER

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

Placebo

Exercise Program BEHAVIORAL

All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.

Fluoxetine Hydrochloride; Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of British Columbia: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• University of Calgary: collaborator
• Dalhousie University: collaborator
• Parkwood Hospital, London, Ontario: collaborator
• Riverview Health Centre Foundation: collaborator
• Memorial University of Newfoundland: collaborator
• Applied Health Research Centre: collaborator
• Brain Canada: collaborator
• Heart and Stroke Foundation Canadian Partnership for Stroke Recovery: collaborator

Study Sites (8)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of British Columbia & GF Strong Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1A 1E5, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 3J5, Canada

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

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Related Links

• Research breakthrough to revolutionize stroke treatment
• Tracking Heart Disease and Stroke in Canada

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Motor Activity

Interventions

Fluoxetine; Sugars; Resistance Training

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Carbohydrates; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Bayley, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Courtney Pollock, PhD

  University of British Columbia & GF Strong Rehab Centre

  PRINCIPAL INVESTIGATOR

• Bradley MacIntosh, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Sean Dukelow, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Sepideh Pooyania, MD

  Riverview Health Centre

  PRINCIPAL INVESTIGATOR

• Michelle Ploughman, PhD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

• Marilyn Mackay-Lyons, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Robert Teasell, MD

  Parkwood Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: January 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

CA (8)