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

Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Drug: Escitalopram; Other: Rehabilitative treatment; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Physical medicine & rehabilitation Dept AOU Maggiore della Carità
    • Contact: Lorenzo Coppo, MD; Phone Number: 003903213733373; Email: lorenzo.coppo@inwind.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: ATC N06AB10; Other: Rehabilitative treatment; Rehabilitative treatment
Placebo Comparator: Rehabilitation + Placebo; Rehabilitative treatment + Non active Placebo tablets for 6 months	Other: Rehabilitative treatment; Rehabilitative treatment; Drug: Placebo; Rehabilitative treatment + oral inactive placebo for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Independence Measure	Enrollment, 2 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mini-mental state examination (MMSE)	Enrollment, 2 and 6 months
Trunk Control Test	Enrollment, 2 and 6 months
Canadian Stroke Scale	Enrollment, 2 and 6 months
Motricity Index	Enrollment, 2 and 6 months
Token test	Enrollment, 2 and 6 months
The Bells Test	Enrollment, 2 and 6 months
Stroop Test	Enrollment, 2 and 6 months
Wisconsin Card Sorting test	Enrollment, 2 and 6 months
Verbal Fluency	Enrollment, 2 and 6 months
Raven's Matrices Test	Enrollment, 2 and 6 months
Trail Making A-B Test	Enrollment, 2 and 6 months
Center for Epidemiological Studies Depression Scale	Enrollment, 2 and 6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2010
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: August 26, 2009
• First Submitted That Met QC Criteria: August 26, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): August 27, 2009
• Last Update Submitted That Met QC Criteria: August 26, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Treatment Outcome; Antidepressive Agents,Second-Generation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 49CE 8/08