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

NCT ID: NCT00967408

Last Updated: 2009-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Stroke

Keywords

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Stroke Antidepressive Agents,Second-Generation Treatment Outcome Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rehabilitation + 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.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type 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.

Rehabilitative treatment

Intervention Type OTHER

Rehabilitative treatment

Rehabilitation + Placebo

Rehabilitative treatment + Non active Placebo tablets for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Rehabilitative treatment + oral inactive placebo for 6 months

Rehabilitative treatment

Intervention Type OTHER

Rehabilitative treatment

Interventions

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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.

Intervention Type DRUG

Placebo

Rehabilitative treatment + oral inactive placebo for 6 months

Intervention Type DRUG

Rehabilitative treatment

Rehabilitative treatment

Intervention Type OTHER

Other Intervention Names

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ATC N06AB10

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Physical medicine & Rehabilitation Dpt. AOU Maggiore della Carita

Locations

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Physical medicine & rehabilitation Dept AOU Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Carda, MD

Role: CONTACT

Phone: +3903213734844

Email: [email protected]

Carlo Cisari, MD

Role: CONTACT

Phone: +3903213734828

Email: [email protected]

Facility Contacts

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Lorenzo Coppo, MD

Role: primary

Other Identifiers

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49CE 8/08

Identifier Type: -

Identifier Source: org_study_id