Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
NCT ID: NCT01674868
Last Updated: 2015-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fluoxetine
Subjects will take 20 mg fluoxetine daily for 90 days after stroke
fluoxetine
20 mg daily for 90 days starting day 5-10 after stroke.
placebo
Subjects will take one pill daily for 90 days after stroke.
placebo
subjects will take one pill po daily for 90 days.
Interventions
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fluoxetine
20 mg daily for 90 days starting day 5-10 after stroke.
placebo
subjects will take one pill po daily for 90 days.
Eligibility Criteria
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Inclusion Criteria
* Admission NIHSS item 5 score equal to or \>2 -Able to give informed consent, with surrogate consent acceptable-
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Randie Black-Schaffer MD
Medical Director, Stroke Program
Locations
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Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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FLAN SpauldingRH
Identifier Type: -
Identifier Source: org_study_id
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