Overview

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Withdrawn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