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

NCT ID: NCT02767999

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2022-01-31

Brief Summary

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Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluoxetine

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

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

20 mg of fluoxetine capsule per day from D0 to D90

fMRI

Intervention Type RADIATION

functional resting state MRI

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

cellulose placebo per day from D0 to D90

fMRI

Intervention Type RADIATION

functional resting state MRI

Interventions

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Fluoxetine

20 mg of fluoxetine capsule per day from D0 to D90

Intervention Type DRUG

Placebo

cellulose placebo per day from D0 to D90

Intervention Type DRUG

fMRI

functional resting state MRI

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François CHOLLET, MD PhD

Role: STUDY_DIRECTOR

University Hospital, Toulouse

Locations

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Hôpital Pellegrin

Bordeaux, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/14/7388

Identifier Type: -

Identifier Source: org_study_id

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