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Fluoxetine Opens Window to Improve Motor Recovery After Stroke (FLOW)

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Behavioral: Exercise Program
Other: Placebo
Drug: Fluoxetine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03448159
18-6002
CTO #1465

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 25 years of age or older
  2. Days post stroke must be between 2 to 12 months when enrolled (i.e. day of consent)
  3. Patient-reported hemiparesis of the lower extremity

Exclusion criteria

  1. Patients with subarachnoid hemorrhage
  2. Pre-morbid modified Rankin score > 2
  3. Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
  4. Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment
  5. Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment
  6. Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
  7. Resting blood pressure exceeding 180/100mmHg
  8. Requires more than a one person assist for transfer
  9. Planned surgery that would affect participation in the trial
  10. Participating in another formal lower limbs exercise program more than one day per week
  11. 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)
  12. History of glaucoma
  13. Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion
  14. History of convulsive disorders
  15. Potential pregnancy (per screening algorithm)
  16. Patients with an ongoing history of illicit drug use and/or alcohol abuse
  17. Patient unwilling or unable to comply with trial requirements
  18. Patient unable to understand English or communicate with the study team with staff support or translation services

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups, including a placebo group

Fluoxetine Hydrochloride
Experimental group
Description:
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).
Treatment:
Behavioral: Exercise Program
Drug: Fluoxetine Hydrochloride
Placebo
Placebo Comparator group
Description:
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).
Treatment:
Behavioral: Exercise Program
Other: Placebo

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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