- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767999
Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke (RECONISE)
August 25, 2023 updated by: University Hospital, Toulouse
Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marianne BARBIEUX-GUILLOT, MD
- Phone Number: 33 05.61.77.77.90
- Email: barbieux-guillot.m@chu-toulouse.fr
Study Locations
-
-
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Bordeaux, France
- Hôpital Pellegrin
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Toulouse, France, 31059
- CHU Toulouse
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluoxetine
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
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20 mg of fluoxetine capsule per day from D0 to D90
functional resting state MRI
|
Placebo Comparator: Placebo
The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
|
functional resting state MRI
cellulose placebo per day from D0 to D90
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 :
|
90 days
|
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.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: François CHOLLET, MD PhD, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2017
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
May 6, 2016
First Submitted That Met QC Criteria
May 6, 2016
First Posted (Estimated)
May 11, 2016
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Ischemic Stroke
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Selective Serotonin Reuptake Inhibitors
- Fluoxetine
Other Study ID Numbers
- RC31/14/7388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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