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

Stroke Clinical Trial

— RECONISE  

Official title:

Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767999
• Other study ID #: RC31/14/7388
• Status: Completed
• Phase: Phase 4
• Start date: February 27, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Fluoxetine
20 mg of fluoxetine capsule per day from D0 to D90
• Placebo
cellulose placebo per day from D0 to D90

Radiation:
• fMRI
functional resting state MRI

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	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.	90 days
Secondary	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.	90 days