Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
NCT ID: NCT02767999
Last Updated: 2023-08-28
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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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2017-02-27
2022-01-31
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
DOUBLE
Study Groups
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Fluoxetine
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
Fluoxetine
20 mg of fluoxetine capsule per day from D0 to D90
fMRI
functional resting state MRI
Placebo
The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
Placebo
cellulose placebo per day from D0 to D90
fMRI
functional resting state MRI
Interventions
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Fluoxetine
20 mg of fluoxetine capsule per day from D0 to D90
Placebo
cellulose placebo per day from D0 to D90
fMRI
functional resting state MRI
Eligibility Criteria
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Inclusion Criteria
* Cortical or subcortical stroke
* National Institute of Health Stroke Scale NIHSS\>12 or motor NIHSS\>6 at inclusion
* MRI-proved ischemic stroke
Exclusion Criteria
* alcoholism
* ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption \< 1 month
* allergic reaction after SSRI administration
* MRI contraindication
* NIHSS\>22
* Severe aphasia
* Coma
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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François CHOLLET, MD PhD
Role: STUDY_DIRECTOR
University Hospital, Toulouse
Locations
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Hôpital Pellegrin
Bordeaux, , France
CHU Toulouse
Toulouse, , France
Countries
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Other Identifiers
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RC31/14/7388
Identifier Type: -
Identifier Source: org_study_id
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