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

Phase 4

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Escitalopram; Other: Rehabilitative treatment

• Registration Number: NCT00967408
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Last Update Submitted: 2009-08-26
• Study First Posted: 2009-08-27
• Last Update Posted: 2009-08-27
• Primary Completion: 2010-07
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation + Escitalopram	Rehabilitative treatment	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	Rehabilitative treatment + Non active Placebo tablets for 6 months
Rehabilitation + Placebo	Rehabilitative treatment	Rehabilitative treatment + Non active Placebo tablets for 6 months
Rehabilitation + Escitalopram	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.

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure	Enrollment, 2 and 6 months

Secondary Outcome Measures

Name	Time	Method
Mini-mental state examination (MMSE)	Enrollment, 2 and 6 months
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
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

Trial Locations

Locations (1)

Physical medicine & rehabilitation Dept AOU Maggiore della Carità; 🇮🇹 Novara, Italy