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

Stroke Clinical Trial

Official title:

Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00967408
• Other study ID #: 49CE 8/08
• Status: Recruiting
• Phase: Phase 4
• First received: August 26, 2009
• Last updated: August 26, 2009
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2009
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Stefano Carda, MD
• Phone: +3903213734844
• Email: stefano.carda[@]virgilio.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Placebo
Rehabilitative treatment + oral inactive placebo for 6 months

Other:
• Rehabilitative treatment
Rehabilitative treatment

Locations

Country	Name	City	State
Italy	Physical medicine & rehabilitation Dept AOU Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Measure		Enrollment, 2 and 6 months	No
Secondary	Mini-mental state examination (MMSE)		Enrollment, 2 and 6 months	No
Secondary	Trunk Control Test		Enrollment, 2 and 6 months	No
Secondary	Canadian Stroke Scale		Enrollment, 2 and 6 months	No
Secondary	Motricity Index		Enrollment, 2 and 6 months	No
Secondary	Token test		Enrollment, 2 and 6 months	No
Secondary	The Bells Test		Enrollment, 2 and 6 months	No
Secondary	Stroop Test		Enrollment, 2 and 6 months	No
Secondary	Wisconsin Card Sorting test		Enrollment, 2 and 6 months	No
Secondary	Verbal Fluency		Enrollment, 2 and 6 months	No
Secondary	Raven's Matrices Test		Enrollment, 2 and 6 months	No
Secondary	Trail Making A-B Test		Enrollment, 2 and 6 months	No
Secondary	Center for Epidemiological Studies Depression Scale		Enrollment, 2 and 6 months	No