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

Recruiting

Phase 4 Results N/A

Trial Description

Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Detailed 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.

Conditions

Interventions

  • Fluoxetine (Prozac®)Drug
    Other Names: Patients receiving fluoxetine
    Intervention Desc: 20 mg of fluoxetine capsule per day from D0 to D90
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: One group will take a 20 mg of fluoxetine capsule per day from D0 to D90.
  • Placebo Drug
    Intervention Desc: cellulose placebo per day from D0 to D90
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: The other group will take a cellulose placebo per day from D0 to D90.
  • Functional resting state MRI Radiation
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: One group will take a 20 mg of fluoxetine capsule per day from D0 to D90.
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: The other group will take a cellulose placebo per day from D0 to D90.
  • FMRI Radiation
    Intervention Desc: functional resting state MRI
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: The other group will take a cellulose placebo per day from D0 to D90 and have fMRI

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Intracerebral connectivity in the motor network between fluoxetine and placebo group. 90 days No
Secondary Intracerebral connectivity in the motor network between good responders patients 90 days No
Secondary Intracerebral connectivity in the motor network between non-responders patients 90 days No

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