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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02767999

Acronym

RECONISE

Enrollment

Registered

2016-05-11

Start date

2017-02-27

Completion date

2022-01-31

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Acute ischemic stroke

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.

Interventions

DRUGFluoxetine

20 mg of fluoxetine capsule per day from D0 to D90

DRUGPlacebo

cellulose placebo per day from D0 to D90

RADIATIONfMRI

functional resting state MRI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026