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

University Hospital Maggiore della Carità of Novara

Status and phase: Unknown; Phase 4

Conditions: Stroke

Treatments: Drug: Escitalopram; Drug: Placebo; Other: Rehabilitative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00967408

49CE 8/08

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Rehabilitation + Escitalopram

Experimental group

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.

Treatment:

Other: Rehabilitative treatment

Drug: Escitalopram

Rehabilitation + Placebo

Placebo Comparator group

Description:

Rehabilitative treatment + Non active Placebo tablets for 6 months

Treatment:

Drug: Placebo

Other: Rehabilitative treatment