Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
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.