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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT00967408
First received: August 26, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: Escitalopram
Drug: Placebo
Other: Rehabilitative treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • Functional Independence Measure [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mini-mental state examination (MMSE) [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Trunk Control Test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Canadian Stroke Scale [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Motricity Index [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Token test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • The Bells Test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Stroop Test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Wisconsin Card Sorting test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Verbal Fluency [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Raven's Matrices Test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Trail Making A-B Test [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies Depression Scale [ Time Frame: Enrollment, 2 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ATC N06AB10
Other: Rehabilitative treatment
Rehabilitative treatment
Placebo Comparator: Rehabilitation + Placebo
Rehabilitative treatment + Non active Placebo tablets for 6 months
Drug: Placebo
Rehabilitative treatment + oral inactive placebo for 6 months
Other: Rehabilitative treatment
Rehabilitative treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967408

Contacts
Contact: Stefano Carda, MD +3903213734844 stefano.carda@virgilio.it
Contact: Carlo Cisari, MD +3903213734828 cisari@tin.it

Locations
Italy
Physical medicine & rehabilitation Dept AOU Maggiore della Carità Recruiting
Novara, Italy, 28100
Contact: Lorenzo Coppo, MD    003903213733373    lorenzo.coppo@inwind.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
  More Information

No publications provided

Responsible Party: Stefano Carda, MD, Physical medicine & Rehabilitation Dpt. AOU Maggiore della Carita
ClinicalTrials.gov Identifier: NCT00967408     History of Changes
Other Study ID Numbers: 49CE 8/08
Study First Received: August 26, 2009
Last Updated: August 26, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
Stroke
Antidepressive Agents,Second-Generation
Treatment Outcome
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Antidepressive Agents
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014