Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke Patients

Study Overview
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Brief Summary
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Rehabilitative treatment in stroke survivors has shown to be effective in improving functional outcome and reducing dependency. Plasticity of the central nervous system, along with coping strategies and adaptations, seems to play a key role in functional recovery. Some data support the hypothesis that drug which improve dopaminergic, serotoninergic and noradrenergic transmission in the central nervous system could improve recovery in stroke patients. In this population, antidepressants as selective serotonin reuptake inhibitors (SSRI) are associated to better outcomes, as evidenced by small clinical trials. However, since depression is a common consequence of stroke, observed improvements could be biased by the action of these drugs on depressive symptoms, thus improving participation in rehabilitative treatment. The hypothesis of this study is that SSRI could improve functional outcome in stroke survivors not only because of their action on depressive symptoms, but mainly because of a direct effect on neural repair and neuronal growth. The aim of the study is to evaluate the effect of a SSRI, escitalopram, on functional outcome of stroke patients.

Official Title
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Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Placebo
* Other: Rehabilitative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both gender age > 18 years first ischaemic and haemorrhagic stroke Exclusion Criteria: unstable medical conditions unable to understand study aims and procedures severe aphasia other progressive neurological disease previous or concomitant psychiatric illness patients not willing to participate to the study

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation + Escitalopram<br>Rehabilitative treatment + Oral Escitalopram 5 mg/day for the first week, 10 mg/day from second to fourth week and 20 mg/day until 6th month. | Drug: Escitalopram<br>* Rehabilitative treatment + Oral Escitalopram 5 mg/day for the first week, 10 mg/day from second to fourth week and 20 mg/day until 6th month.<br>* Other names: ATC N06AB10;Other: Rehabilitative treatment<br>* Rehabilitative treatment<br>|
| Placebo Comparator: Rehabilitation + Placebo<br>Rehabilitative treatment + Non active Placebo tablets for 6 months | Drug: Placebo<br>* Rehabilitative treatment + oral inactive placebo for 6 months<br>Other: Rehabilitative treatment<br>* Rehabilitative treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure |  | Enrollment, 2 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-mental state examination (MMSE) |  | Enrollment, 2 and 6 months | 
| Trunk Control Test |  | Enrollment, 2 and 6 months | 
| Canadian Stroke Scale |  | Enrollment, 2 and 6 months | 
| Motricity Index |  | Enrollment, 2 and 6 months | 
| Token test |  | Enrollment, 2 and 6 months | 
| The Bells Test |  | Enrollment, 2 and 6 months | 
| Stroop Test |  | Enrollment, 2 and 6 months | 
| Wisconsin Card Sorting test |  | Enrollment, 2 and 6 months | 
| Verbal Fluency |  | Enrollment, 2 and 6 months | 
| Raven's Matrices Test |  | Enrollment, 2 and 6 months | 
| Trail Making A-B Test |  | Enrollment, 2 and 6 months | 
| Center for Epidemiological Studies Depression Scale |  | Enrollment, 2 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation