Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
RECONISE
Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
1 other identifier
interventional
25
1 country
2
Brief Summary
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 stroke
Started Feb 2017
Typical duration for phase_4 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedAugust 28, 2023
August 1, 2023
4.9 years
May 6, 2016
August 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intracerebral connectivity in the motor network between fluoxetine and placebo group.
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.
90 days
Secondary Outcomes (2)
Intracerebral connectivity in the motor network between good responders patients
90 days
Intracerebral connectivity in the motor network between non-responders patients
90 days
Study Arms (2)
Fluoxetine
EXPERIMENTALOne group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
Placebo
PLACEBO COMPARATORThe other group will take a cellulose placebo per day from D0 to D90 and have fMRI
Interventions
Eligibility Criteria
You may qualify if:
- First-ever ischemic stroke
- Cortical or subcortical stroke
- MRI-proved ischemic stroke
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital Pellegrin
Bordeaux, France
CHU Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
François CHOLLET, MD PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 11, 2016
Study Start
February 27, 2017
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
August 28, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share