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Completed

NCT Number: NCT02767999

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

Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

20 mg of fluoxetine capsule per day from D0 to D90

Placebo

Drug

cellulose placebo per day from D0 to D90

fMRI

Radiation

functional resting state MRI

Primary outcomes

  1. Intracerebral connectivity in the motor network between fluoxetine and placebo group.

    Time frame: 90 days

    Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.

Secondary outcomes

  1. Intracerebral connectivity in the motor network between good responders patients

    Time frame: 90 days

    Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in fluoxetine and placebo good responders patients, defined by :

    • 8 points gain on the National Institute of Health Stroke Scale (NIHSS), assessed between D0 and D30 and between D0 and D90
    • or 2 points gain on the modified Rankin score (mRS) assessed between D0 and D30 and between D0 and D90.

  2. Intracerebral connectivity in the motor network between non-responders patients

    Time frame: 90 days

    Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study

Acronym: RECONISE

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 11, 2016
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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