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unable to find patients meeting inclusion/exclusion criteria
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental | Subjects will take 20 mg fluoxetine daily for 90 days after stroke |
|
| placebo | Placebo Comparator | Subjects will take one pill daily for 90 days after stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluoxetine | Drug | 20 mg daily for 90 days starting day 5-10 after stroke. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| placebo |
| Drug |
subjects will take one pill po daily for 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |