Stroke
Conditions
Keywords
Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation
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.
Interventions
DRUGEscitalopram
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.
DRUGPlacebo
Rehabilitative treatment + oral inactive placebo for 6 months
Rehabilitative treatment
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Independence Measure | Enrollment, 2 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mini-mental state examination (MMSE) | 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 |
| Stroop Test | Enrollment, 2 and 6 months |
Countries
Italy
Contacts
Primary ContactStefano Carda, MD
Backup ContactCarlo Cisari, MD
Outcome results
None listed