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

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Fluoxetine; Radiation: fMRI

• Registration Number: NCT02767999
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-11
• Study Start: 2017-02-27
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
Fluoxetine	fMRI	One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
Placebo	fMRI	The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
Fluoxetine	Fluoxetine	One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

CHU Toulouse; 🇫🇷 Toulouse, France

Hôpital Pellegrin; 🇫🇷 Bordeaux, France