Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation + Escitalopram | Experimental | 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. |
|
| Rehabilitation + Placebo | Placebo Comparator | Rehabilitative treatment + Non active Placebo tablets for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure | Enrollment, 2 and 6 months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Carda, MD | Contact | +3903213734844 | stefano.carda@virgilio.it | |
| Carlo Cisari, MD | Contact | +3903213734828 | cisari@tin.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical medicine & rehabilitation Dept AOU Maggiore della Carità | Recruiting | Novara | 28100 | Italy |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Rehabilitative treatment + oral inactive placebo for 6 months |
|
| Rehabilitative treatment | Other | Rehabilitative treatment |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |