Clinical trial NCT00967408: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Keywords: Stroke
Antidepressive Agents,Second-Generation
Treatment Outcome
Rehabilitation
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Functional Independence Measure
timeFrame: Enrollment, 2 and 6 months
Secondary outcomes:
measure: Mini-mental state examination (MMSE)
timeFrame: Enrollment, 2 and 6 months
measure: Trunk Control Test
timeFrame: Enrollment, 2 and 6 months
measure: Canadian Stroke Scale
timeFrame: Enrollment, 2 and 6 months
measure: Motricity Index
timeFrame: Enrollment, 2 and 6 months
measure: Token test
timeFrame: Enrollment, 2 and 6 months
measure: The Bells Test
timeFrame: Enrollment, 2 and 6 months
measure: Stroop Test
timeFrame: Enrollment, 2 and 6 months
measure: Wisconsin Card Sorting test
timeFrame: Enrollment, 2 and 6 months
measure: Verbal Fluency
timeFrame: Enrollment, 2 and 6 months
measure: Raven's Matrices Test
timeFrame: Enrollment, 2 and 6 months
measure: Trail Making A-B Test
timeFrame: Enrollment, 2 and 6 months
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Enrollment, 2 and 6 months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Physical medicine & rehabilitation Dept AOU Maggiore della Carità
Study officials:
References: