NCT01674868

Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke

Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	fluoxetine	20 mg daily for 90 days starting day 5-10 after stroke.
DRUG	placebo	subjects will take one pill po daily for 90 days.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-08-29
• Last updated: 2015-06-16

Locations

1 site across 1 country: United States