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

Withdrawn

Phase N/A Results N/A

Update History

17 Jun '15
A location was updated in Boston.
New
The overall status was removed for Spaulding Rehabilitation Hospital.
22 Jul '14
The Summary of Purpose was updated.
New
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.
Old
This pilot study will recruit 16-25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), an 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, and will evaluate the durability of observed effects in all 3 domains. 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.
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Age 18 and older - Ischemic infarction within the past 10 days - Fluent in English - May require assistance of surrogate to give consent - Functional Communication Measure >=1 for patients with inattention - Functional Communication Measure >=3 for patients with aphasia - NIH Stroke Scale < 20 on admission to Spaulding - Able to follow directions and participate in 2 hrs of testing with short breaks Exclusion Criteria: - Pregnant or lactating - Hemianopsia - Active depression on admission to Spaulding - Taking an SSRI or other medication likely to have adverse interaction with an SSRI - Resides too far away to return for follow-up testing - Unable to give consent and no surrogate available
10 Apr '13
A location was updated in Boston.
New
The overall status was removed for Spaulding Rehabilitation Hospital.