FLOW Trial: FLuoxetine to Open the critical time period Window to improve motor recovery after stroke
The FLOW trial will evaluate the effect of combining an antidepressant (e.g. fluoxetine, known more commonly as Prozac) with exercise rehabilitation across multiple Canadian sites in 176 stroke patients. Fluoxetine has been shown in animal models to keep open the period of recovery post-stroke. The trial rationale is that motor function will be significantly improved by pairing fluoxetine with a task-based exercise program. Funding for the FLOW Trial is being provided by a grant from the Brain Canada Foundation in partnership with CPSR.
Who can apply
- Are 25 years of age or older
- Experienced a stroke between 2 to 12 months ago
- Have significant leg weakness in at least one leg
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 supervised exercise program.
- Take the trial medication for 19-21 weeks
- 3 additional study visits
Parking and/or travel expenses will be provided.
If you decide to participate then you will be "randomized" into one of two groups. Randomization means that you will have an equal (50/50) chance of being placed in either group. Neither you, nor the study staff can choose what group you will be in. This is also a double-blind study, which means that neither you, nor the study staff, will know which group you are in.
88 patients will be enrolled in each group of the study. Both groups will receive a 12-week exercise program (in addition to standard of care rehabilitation), but only one group (the intervention group) will receive the active drug fluoxetine. The other group will receive a placebo. A placebo is a pill that looks the same as the fluoxetine pill but actually contains no active ingredients. It is given in this study to reduce the chances of believing that one’s recovery is improving because one is receiving a new drug. We don’t know if fluoxetine is better than standard care, so we are doing this study to try and find that out.
This study is being run at multiple sites across Canada. For more information about the trial, please contact the site coordinator near you (click on FLOW Trial to see list of sites and contact information).
You can also contact the site coordinator at Toronto Rehab for information: Evan Foster E-mail: Evan.Foster@uhn.ca Tel: 416-597-3422 ext. 3362