Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke (FLAN)

Mass General Brigham

Status

Withdrawn

Conditions

Stroke

Treatments

Drug: fluoxetine

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01674868

FLAN SpauldingRH

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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