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
Recruitment status was Recruiting
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013