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

NCT00967408 | Unknown Phase 4

• 1 other identifier: 49CE 8/08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Antidepressive Agents,Second-Generation; Treatment Outcome; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure

  Enrollment, 2 and 6 months

Secondary Outcomes (12)

• 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

Study Arms (2)

Rehabilitation + Escitalopram

EXPERIMENTAL

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; Other: Rehabilitative treatment

Rehabilitation + Placebo

PLACEBO COMPARATOR

Rehabilitative treatment + Non active Placebo tablets for 6 months

Drug: Placebo; Other: Rehabilitative treatment

Interventions

Escitalopram 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.

Also known as: ATC N06AB10

Rehabilitation + Escitalopram

Placebo DRUG

Rehabilitative treatment + oral inactive placebo for 6 months

Rehabilitation + Placebo

Rehabilitative treatment OTHER

Rehabilitative treatment

Rehabilitation + Escitalopram; Rehabilitation + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender
• age \> 18 years
• first ischaemic and haemorrhagic stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

Physical medicine & rehabilitation Dept AOU Maggiore della Carità

Novara, 28100, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Stefano Carda, MD

CONTACT

+3903213734844; stefano.carda@virgilio.it

Carlo Cisari, MD

CONTACT

+3903213734828; cisari@tin.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2011
• Last Updated: August 27, 2009

Record last verified: 2009-08

Locations

IT (1)