Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Stroke
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Functional Independence Measure
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Rehabilitation + Escitalopram
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.
Intervention: Escitalopram
Rehabilitation + Escitalopram
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.
Intervention: Rehabilitative treatment
Rehabilitation + Placebo
Rehabilitative treatment + Non active Placebo tablets for 6 months
Intervention: Placebo
Rehabilitation + Placebo
Rehabilitative treatment + Non active Placebo tablets for 6 months
Intervention: Rehabilitative treatment
Outcomes
Primary Outcomes
Functional Independence Measure
Time Frame: Enrollment, 2 and 6 months
Secondary Outcomes
- Mini-mental state examination (MMSE)(Enrollment, 2 and 6 months)
- Trunk Control Test(Enrollment, 2 and 6 months)
- The Bells Test(Enrollment, 2 and 6 months)
- Stroop 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)
- 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)