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Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoxetine | Experimental | One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI |
|
| Placebo | Placebo Comparator | The other group will take a cellulose placebo per day from D0 to D90 and have fMRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoxetine | Drug | 20 mg of fluoxetine capsule per day from D0 to D90 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intracerebral connectivity in the motor network between fluoxetine and placebo group. | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intracerebral connectivity in the motor network between good responders patients | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in fluoxetine and placebo good responders patients, defined by :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François CHOLLET, MD PhD | University Hospital, Toulouse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | France | ||||
| CHU Toulouse |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| 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 |
cellulose placebo per day from D0 to D90 |
|
| fMRI | Radiation | functional resting state MRI |
|
| 90 days |
| Intracerebral connectivity in the motor network between non-responders patients | Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group. | 90 days |
| Toulouse |
| 31059 |
| France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |