Fluoxetine on Motor Rehabilitation After Ischemic Stroke

Study Overview
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Brief Summary
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Recovery from stroke is a major process and, except for acute intravenous thrombolysis, no treatment able to enhance recovery has yet been validated. Some drugs may have a positive effect when combined with physical rehabilitation. Previous studies have shown a potential effect of catecholaminergic drugs on cerebral plasticity of stroke patients. In 2001, our group has demonstrated in a small group of stroke patients (n=8) that a single dose of fluoxetine (Selective Serotonin Reuptake Inhibitor - SSRI) improved motor performance and modulated cerebral plasticity. We conducted a phase IIb prospective, double-blind, randomized, placebo controlled study to assess the effect of a daily treatment with fluoxetin (20 mg) on motor performance in patients with mild to severe motor deficit after ischemic stroke.

Detailed Description
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We project to include in the study a maximum of 168 patients with a recent (5 to 10 days) ischemic stroke and unilateral motor deficit in order to obtain 100 completed patients. Nine stroke centers in France are involved. Each patient will receive daily, during three months, 20 mg of fluoxetin or placebo. Patients will be evaluated at inclusion, day 30, M3 (3 months), M12.

Official Title
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Effects of 3 Months Daily Treatment With Selective Serotonin Reuptake Inhibitor (SSRI, Fluoxetine) on Motor Rehabilitation After Ischemic Stroke. FLAME Trial

Conditions
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Ischemic Stroke, Motor Impairment

Intervention / Treatment
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* Drug: fluoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged from 18 to 85 No motor relapse from a previous stroke Inclusion from day 5 to day 10 after stroke Ischemic stroke with unilateral motor deficit Motor NIHSS ≥ 5 on the affected side of the body NIHSS < 20 Fugl Meyer Motor Scale <55 Modified Rankin Scale between 1 and 5 Informed consent obtained from the subject or a member of his family Exclusion Criteria: Pregnant or breast-feeding woman Woman able to procreate without valid contraception Subject protected by law Concomitant disease with unfavourable prognosis within 1 year Drug addiction Allergy to fluoxetine Hepatic failure (TGO and TGP >2N) Permanent Renal failure (Creatinin >180micromol/l) Patients treated by tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month Depression requiring pharmacological treatment Previous stroke with motor relapse Fugl Meyer Motor Scale > 55 Modified Rankin Scale = 0 or 6 Patients needing carotid surgery within 3 months Aphasia preventing correct evaluation of motor and depression scales.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fluoxetine | Drug: fluoxetine<br>* fluoxetine per os 20 mg daily<br>* Other names: PROZAC;|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* placebo per os daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression in the Fugl-Meyer Motor Scale |  | M3 (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Stroke Scale |  | M12 (12 months) | 
| NIH stroke scale |  | M3 and M12 | 
| MADRS depression scale |  | M3 and M12 | 
| Modified Rankin scale |  | M3 and M12 | 
| Mortality |  | M3 and M12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke recovery, Pharmacological modulation, Selective Serotonin Reuptake Inhibitor (SSRI), Fluoxetine, Brain plasticity, Ischemic Stroke and Motor impairment, Modulation of recovery and cerebral plasticity by Fluoxetine