NCT00967408

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

Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Rehabilitative treatment + oral inactive placebo for 6 months
OTHER	Rehabilitative treatment	Rehabilitative treatment

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-07-01
• Completion: 2011-10-01
• First posted: 2009-08-27
• Last updated: 2009-08-27

Locations

1 site across 1 country: Italy