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Selective Serotonin Reuptake Inhibitor

Fluoxetine Hydrochloride for Nervous System Disorders (FLOW Trial)

Phase 2
Waitlist Available
Led By Courtney Pollock, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Awards & highlights

FLOW Trial Summary

This trial is testing whether combining Prozac and exercise can help improve motor skills after a stroke.

Eligible Conditions
  • Nervous System Disorders
  • Brain Diseases
  • Vascular Disease
  • Stroke
  • Central Nervous System Disorders
  • Brain Ischemia

FLOW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following completion of the 12-week exercise intervention and 6-months post-exercise intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and following completion of the 12-week exercise intervention and 6-months post-exercise intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
6 Minute Walk Test / 10 Meter Walk Test
Berg Balance Assessment
Body Mass Index
+11 more

Side effects data

From 2001 Phase 1 trial • 26 Patients • NCT01247272
19%
Headache
8%
Nausea
4%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluoxetine Hydrochloride (Test) First
Prozac® Weekly (Reference) First

FLOW Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fluoxetine HydrochlorideExperimental Treatment2 Interventions
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).
Group II: PlaceboPlacebo Group2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine Hydrochloride
2019
Completed Phase 2
~220
Exercise Program
2016
Completed Phase 3
~4930

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,466 Previous Clinical Trials
484,313 Total Patients Enrolled
Dalhousie UniversityOTHER
167 Previous Clinical Trials
403,086 Total Patients Enrolled
Applied Health Research CentreOTHER
22 Previous Clinical Trials
70,984 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
StrokeJournal
Association Between Gait Asymmetry and Brain Lesion Location in Stroke Patients
Alexander, Lisa D., Sandra E. Black, Kara K. Patterson, Fuqiang Gao, Cynthia J. Danells, and William E. McIlroy. 2009. “Association Between Gait Asymmetry and Brain Lesion Location in Stroke Patients”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.108.527374.
Implementation ScienceJournal
Facilitated Interprofessional Implementation of a Physical Rehabilitation Guideline for Stroke in Inpatient Settings: Process Evaluation of a Cluster Randomized Trial
Salbach, Nancy M., on behalf of the Stroke Canada Optimization of Rehabilitation By Evidence – Implementation Trial (SCORE-IT) Team, Sharon Wood-Dauphinee, Johanne Desrosiers, Janice J. Eng, Ian D. Graham, Susan B. Jaglal, et al.. 2017. “Facilitated Interprofessional Implementation of a Physical Rehabilitation Guideline for Stroke in Inpatient Settings: Process Evaluation of a Cluster Randomized Trial”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-017-0631-7.
Journal of NeuroscienceJournal
Efficacy of Rehabilitative Experience Declines with Time After Focal Ischemic Brain Injury
Biernaskie, J.. 2004. “Efficacy of Rehabilitative Experience Declines with Time After Focal Ischemic Brain Injury”. Journal of Neuroscience. Society for Neuroscience. doi:10.1523/jneurosci.3834-03.2004.
New England Journal of MedicineJournal
Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke
Goyal, Mayank, Andrew M. Demchuk, Bijoy K. Menon, Muneer Eesa, Jeremy L. Rempel, John Thornton, Daniel Roy, et al.. 2015. “Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1414905.
~8 spots leftby Apr 2025
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