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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767999
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Condition or disease Intervention/treatment Phase
Stroke Drug: Fluoxetine Drug: Placebo Radiation: fMRI Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fluoxetine
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
Drug: Fluoxetine
20 mg of fluoxetine capsule per day from D0 to D90

Radiation: fMRI
functional resting state MRI

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

Radiation: fMRI
functional resting state MRI




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767999


Contacts
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Contact: Marianne BARBIEUX-GUILLOT, MD 05.61.77.77.90 ext 33 barbieux-guillot.m@chu-toulouse.fr

Locations
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France
Hôpital Pellegrin Not yet recruiting
Bordeaux, France
Contact: Igor SIBON, Doctor       igor.sibon@chu-bordeaux.fr   
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Marianne BARBIEUX-GUILLOT, MD    05.61.77.77.90 ext 33    barbieux-guillot.m@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: François CHOLLET, MD PhD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02767999    
Other Study ID Numbers: RC31/14/7388
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Acute ischemic stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors