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

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

Study Locations

      • Bordeaux, France
        • Hôpital Pellegrin
      • Toulouse, France, 31059
        • CHU Toulouse

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
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.
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 :

  • 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.
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.

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

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.

Clinical Trials on Stroke

Clinical Trials on Fluoxetine

3
Subscribe