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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Unknown status

CT.gov ID

NCT02767999

Collaborator

(none)

Enrollment

Locations

Arms

45.1

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 27, 2017

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intracerebral connectivity in the motor network between fluoxetine and placebo group. [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

Intracerebral connectivity in the motor network between good responders patients [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.
Intracerebral connectivity in the motor network between non-responders patients [90 days]
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, in non-responders patients of fluoxetine and placebo group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Pellegrin	Bordeaux		France
2	CHU Toulouse	Toulouse		France	31059

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Study Director: François CHOLLET, MD PhD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT02767999

Other Study ID Numbers:

RC31/14/7388

First Posted:

May 11, 2016

Last Update Posted:

Jul 30, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Acute ischemic stroke

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Fluoxetine

Study Results

No Results Posted as of Jul 30, 2020