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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: fluoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine<br>Subjects will take 20 mg fluoxetine daily for 90 days after stroke | Drug: fluoxetine<br>* 20 mg daily for 90 days starting day 5-10 after stroke.<br>|
| Placebo Comparator: placebo<br>Subjects will take one pill daily for 90 days after stroke. | Drug: placebo<br>* subjects will take one pill po daily for 90 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Motor Scale (FMMS) | change in FMMS score | baseline to 90 days | 
| Fugl-Meyer Motor Scale (FMMS) | change in FMMS | baseline to 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Aphasia Battery | change in Western Aphasia Quotient | baseline to 90 days | 
| Behavioral Inattention Test (BIT) | change in BIT | baseline to 90 days | 
| Behavioral Inattention Test (BIT) | change in BIT | baseline to 180 days | 
| Functional Independence Measure | change in FIM | baseline to discharge | 
| Fatigue Severity Scale |  | baseline to 90 days | 
| Beck Depression Inventory |  | baseline to 90 days | 
| Western Aphasia Battery | change in Western Aphasia Quotient | baseline to 180 days | 
| Beck Depression Inventory |  | baseline to 180 days | 
| Fatigue Severity Scale |  | baseline to 180 days | 
| modified Rankin Scale |  | baseline to 90 days | 
| modified Rankin Scale |  | baseline to 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, recovery, fluoxetine, aphasia, neglect, motor