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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Fluoxetine
Placebo
fMRI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute ischemic stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pellegrin
  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluoxetine

Placebo

Arm Description

One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2016
Last Updated
August 25, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02767999
Brief Title
Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke
Acronym
RECONISE
Official Title
Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Experimental
Arm Description
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Description
20 mg of fluoxetine capsule per day from D0 to D90
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
cellulose placebo per day from D0 to D90
Intervention Type
Radiation
Intervention Name(s)
fMRI
Intervention Description
functional resting state MRI
Primary Outcome Measure Information:
Title
Intracerebral connectivity in the motor network between fluoxetine and placebo group.
Description
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Intracerebral connectivity in the motor network between good responders patients
Description
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.
Time Frame
90 days
Title
Intracerebral connectivity in the motor network between non-responders patients
Description
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CHOLLET, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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