Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.

Detailed Description
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Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability, economic and social burden. This is particularly true in developing countries where it accounts for between 20% and 50% of all strokes. Pharmacological and surgical interventions have been attempted to diminish the mortality and disability derived from ICH, with unsuccessful results. Recently the use of Fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery from cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage. This is a randomized, double-blind, placebo-controlled, multicenter clinical trial. This trial will recruit 86 patients with intracerebral hemorrhage of both sexes, ages >18 years, from four Mexican hospitals. The patients will receive either 20mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in Barthel Index, Modified Rankin scale and National Institutes of Health (NIH) Stroke Scale. The outcomes will be measured at day 45±7days and at day 90, for a total of four visits with each subject (at screening and at 0, 45 and 90days).

Official Title
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Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial

Conditions
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Intracerebral Hemorrhage, 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: Patients who had an acute intracerebral hemorrhage within the past 10 days causing hemiparesis or hemiplegia Fugl-Meyer motor scale (FMMS) scores of 55 or less Written informed consent for participation in the trial Exclusion Criteria: Severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20) Premorbid disability, evidenced by residual motor deficit from a previous stroke Comprehension deficit or severe aphasia Previous diagnosis of depression or one of the following: Hospital Anxiety and Depression Scale score ≥11 points Taking antidepressant drugs two weeks before inclusion Taking neuroleptic drugs or benzodiazepines two weeks before inclusion Other major diseases with life expectancy less than 3 months.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Motor Scale score | Change from Baseline in Fugl Meyer Motor Scale score at 90 days | Baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index | Change from Baseline in Barthel Index at 90 days | Baseline and 90 days | 
| modified Rankin Scale | Change from Baseline in modified Rankin Scale at 90 days | Baseline and 90 days | 
| NIH Stroke Scale | Change from Baseline in NIH Stroke Scale at 90 days | Baseline and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Disorders, Cardiovascular Diseases, Intracerebral Hemorrhage, Serotonin Uptake Inhibitors, Therapeutic Uses