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

Recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Escitalopram (Lexapro)Drug
    Other Names: Lexapro
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Rehabilitation + Escitalopram
    Description: 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.
  • Placebo Drug
    Intervention Desc: Rehabilitative treatment + oral inactive placebo for 6 months
    ARM 1: Kind: Experimental
    Label: Rehabilitation + Placebo
    Description: Rehabilitative treatment + Non active Placebo tablets for 6 months
  • Rehabilitative treatment Other
    Intervention Desc: Rehabilitative treatment
    ARM 1: Kind: Experimental
    Label: Rehabilitation + Escitalopram
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Rehabilitation + Placebo
    Description: Rehabilitative treatment + Non active Placebo tablets for 6 months

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Independence Measure Enrollment, 2 and 6 months No
Secondary Mini-mental state examination (MMSE) Enrollment, 2 and 6 months No
Secondary Trunk Control Test Enrollment, 2 and 6 months No
Secondary Canadian Stroke Scale Enrollment, 2 and 6 months No
Secondary Motricity Index Enrollment, 2 and 6 months No
Secondary Token test Enrollment, 2 and 6 months No
Secondary The Bells Test Enrollment, 2 and 6 months No
Secondary Stroop Test Enrollment, 2 and 6 months No
Secondary Wisconsin Card Sorting test Enrollment, 2 and 6 months No
Secondary Verbal Fluency Enrollment, 2 and 6 months No
Secondary Raven's Matrices Test Enrollment, 2 and 6 months No
Secondary Trail Making A-B Test Enrollment, 2 and 6 months No
Secondary Center for Epidemiological Studies Depression Scale Enrollment, 2 and 6 months No

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