This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.
Trial Stopped: unable to find patients meeting inclusion/exclusion criteria
- Fluoxetine (Prozac®)Drug
Other Names: Patients receiving fluoxetine Intervention Desc: 20 mg daily for 90 days starting day 5-10 after stroke. ARM 1: Kind: Experimental Label: Fluoxetine Description: Subjects will take 20 mg fluoxetine daily for 90 days starting at day 5-10 after stroke.
- Placebo Drug
Intervention Desc: subjects will take one pill po daily for 90 days. ARM 1: Kind: Experimental Label: placebo Description: Subjects will take one pill daily for 90 days.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Fugl-Meyer Motor Scale (FMMS)||baseline to 45 days||No|
|Secondary||Western Aphasia Battery||baseline to 45 days||No|
|Secondary||Behavioral Inattention Test (BIT)||baseline to 45 days||No|
|Secondary||Functional Independence Measure||baseline to discharge||No|
|Secondary||Fatigue Severity Scale||baseline to 90 days||No|
|Secondary||Beck Depression Inventory||baseline to 90 days||No|
|Secondary||modified Rankin Scale||baseline to 90 days||No|