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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
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.
Rehabilitative treatment + oral inactive placebo for 6 months
Rehabilitative treatment
Physical medicine & rehabilitation Dept AOU Maggiore della Carità
Novara, Italy
RECRUITINGFunctional Independence Measure
Time frame: Enrollment, 2 and 6 months
Mini-mental state examination (MMSE)
Time frame: Enrollment, 2 and 6 months
Trunk Control Test
Time frame: Enrollment, 2 and 6 months
Canadian Stroke Scale
Time frame: Enrollment, 2 and 6 months
Motricity Index
Time frame: Enrollment, 2 and 6 months
Token test
Time frame: Enrollment, 2 and 6 months
The Bells Test
Time frame: Enrollment, 2 and 6 months
Stroop Test
Time frame: Enrollment, 2 and 6 months
Wisconsin Card Sorting test
Time frame: Enrollment, 2 and 6 months
Verbal Fluency
Time frame: Enrollment, 2 and 6 months
Raven's Matrices Test
Time frame: Enrollment, 2 and 6 months
Trail Making A-B Test
Time frame: Enrollment, 2 and 6 months
Center for Epidemiological Studies Depression Scale
Time frame: Enrollment, 2 and 6 months
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