Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke (RECONISE)

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: Placebo; Drug: Fluoxetine; Radiation: fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02767999

RC31/14/7388

Details and patient eligibility

About

Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First-ever ischemic stroke
• Cortical or subcortical stroke
• National Institute of Health Stroke Scale NIHSS>12 or motor NIHSS>6 at inclusion
• MRI-proved ischemic stroke

Exclusion criteria

• pregnant or breast-feeding women
• alcoholism
• ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption < 1 month
• allergic reaction after SSRI administration
• MRI contraindication
• NIHSS>22
• Severe aphasia
• Coma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Fluoxetine

Experimental group

Description:

One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI

Treatment:

Radiation: fMRI

Drug: Fluoxetine

Placebo

Placebo Comparator group

Description:

The other group will take a cellulose placebo per day from D0 to D90 and have fMRI

Treatment:

Drug: Placebo

Radiation: fMRI