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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Escitalopram
Placebo
Rehabilitative treatment
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical medicine & rehabilitation Dept AOU Maggiore della CaritàRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rehabilitation + Escitalopram

Rehabilitation + Placebo

Arm Description

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 + Non active Placebo tablets for 6 months

Outcomes

Primary Outcome Measures

Functional Independence Measure

Secondary Outcome Measures

Mini-mental state examination (MMSE)
Trunk Control Test
Canadian Stroke Scale
Motricity Index
Token test
The Bells Test
Stroop Test
Wisconsin Card Sorting test
Verbal Fluency
Raven's Matrices Test
Trail Making A-B Test
Center for Epidemiological Studies Depression Scale

Full Information

First Posted
August 26, 2009
Last Updated
August 26, 2009
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
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1. Study Identification

Unique Protocol Identification Number
NCT00967408
Brief Title
Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke Patients
Official Title
Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation + Escitalopram
Arm Type
Experimental
Arm Description
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.
Arm Title
Rehabilitation + Placebo
Arm Type
Placebo Comparator
Arm Description
Rehabilitative treatment + Non active Placebo tablets for 6 months
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
ATC N06AB10
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Rehabilitative treatment + oral inactive placebo for 6 months
Intervention Type
Other
Intervention Name(s)
Rehabilitative treatment
Intervention Description
Rehabilitative treatment
Primary Outcome Measure Information:
Title
Functional Independence Measure
Time Frame
Enrollment, 2 and 6 months
Secondary Outcome Measure Information:
Title
Mini-mental state examination (MMSE)
Time Frame
Enrollment, 2 and 6 months
Title
Trunk Control Test
Time Frame
Enrollment, 2 and 6 months
Title
Canadian Stroke Scale
Time Frame
Enrollment, 2 and 6 months
Title
Motricity Index
Time Frame
Enrollment, 2 and 6 months
Title
Token test
Time Frame
Enrollment, 2 and 6 months
Title
The Bells Test
Time Frame
Enrollment, 2 and 6 months
Title
Stroop Test
Time Frame
Enrollment, 2 and 6 months
Title
Wisconsin Card Sorting test
Time Frame
Enrollment, 2 and 6 months
Title
Verbal Fluency
Time Frame
Enrollment, 2 and 6 months
Title
Raven's Matrices Test
Time Frame
Enrollment, 2 and 6 months
Title
Trail Making A-B Test
Time Frame
Enrollment, 2 and 6 months
Title
Center for Epidemiological Studies Depression Scale
Time Frame
Enrollment, 2 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Carda, MD
Phone
+3903213734844
Email
stefano.carda@virgilio.it
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Cisari, MD
Phone
+3903213734828
Email
cisari@tin.it
Facility Information:
Facility Name
Physical medicine & rehabilitation Dept AOU Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Coppo, MD
Phone
003903213733373
Email
lorenzo.coppo@inwind.it

12. IPD Sharing Statement

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

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