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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spaulding Rehabilitation Hospital
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Ischemic infarction within 15 days

• Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable-

Exclusion Criteria:

• Pre-stroke modified Rankin Scale score equal or .3

• Pregnant or lactating

• Taking an SSRI on admission to SRH

• Taking a medication likely to have adverse interaction with an SSRI

• Unable to return for follow-up testing days 90,180

• Concurrent medial condition likely to worsen patient's functional status over next 6 months

• Unable to competently participate in testing for 45min-2hrs with rest breaks

• for MRI substudy: contraindication to MRI