StrokePhase 4NCT00967408
Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke Patients
A Phase 4 study testing Escitalopram and Rehabilitative treatment in people with Stroke, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Escitalopram and Rehabilitative treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both gender
- age > 18 years
- first ischaemic and haemorrhagic stroke
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Physical medicine & rehabilitation Dept AOU Maggiore della Carità
Novara, 28100
Lorenzo Coppo, MD, 003903213733373, lorenzo.coppo@inwind.it
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Escitalopram, Placebo, Rehabilitative treatment
- Keywords
- Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called ATC N06AB10
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.
PlaceboDrug
Rehabilitative treatment + oral inactive placebo for 6 months
Rehabilitative treatmentOther
Rehabilitative treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Escitalopram; Other: Rehabilitative treatment |
| Rehabilitation + Placebo | Placebo comparator | Rehabilitative treatment + Non active Placebo tablets for 6 months Receives: Drug: Placebo; Other: Rehabilitative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure
Measured: Enrollment, 2 and 6 months
Secondary outcomes (12)
Mini-mental state examination (MMSE)
Measured: Enrollment, 2 and 6 months
Trunk Control Test
Measured: Enrollment, 2 and 6 months
Canadian Stroke Scale
Measured: Enrollment, 2 and 6 months
Motricity Index
Measured: Enrollment, 2 and 6 months
Token test
Measured: Enrollment, 2 and 6 months
The Bells Test
Measured: Enrollment, 2 and 6 months
Stroop Test
Measured: Enrollment, 2 and 6 months
Wisconsin Card Sorting test
Measured: Enrollment, 2 and 6 months
Verbal Fluency
Measured: Enrollment, 2 and 6 months
Raven's Matrices Test
Measured: Enrollment, 2 and 6 months
Trail Making A-B Test
Measured: Enrollment, 2 and 6 months
Center for Epidemiological Studies Depression Scale
Measured: Enrollment, 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967408
- Sponsor's protocol ID
- 49CE 8/08
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke
- ClinicalTrials.gov ID
- NCT00967408
- Acronym / sponsor ID
- 49CE 8/08
- Conditions
- Stroke
- Keywords
- Stroke, Antidepressive Agents,Second-Generation, Treatment Outcome, Rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation + Escitalopram | Experimental | Drug: Escitalopram, Other: Rehabilitative treatmentRehabilitative 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. |
| Rehabilitation + Placebo | Placebo comparator | Drug: Placebo, Other: Rehabilitative treatmentRehabilitative treatment + Non active Placebo tablets for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both gender
- age > 18 years
- first ischaemic and haemorrhagic stroke
Key exclusion criteria (6 listed)
- unstable medical conditions
- unable to understand study aims and procedures
- severe aphasia
- other progressive neurological disease
- previous or concomitant psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: ATC N06AB10Rehabilitative 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 | Rehabilitation + Escitalopram |
| PlaceboRehabilitative treatment + oral inactive placebo for 6 months | Drug | Rehabilitation + Placebo |
| Rehabilitative treatmentRehabilitative treatment | Other | Rehabilitation + Escitalopram, Rehabilitation + Placebo |
Primary outcome
Functional Independence Measure
Time frame: Enrollment, 2 and 6 months
12 secondary outcomes
Mini-mental state examination (MMSE)
Time frame: Enrollment, 2 and 6 months
Trunk Control Test
Time frame: Enrollment, 2 and 6 months
Canadian Stroke Scale
Time frame: Enrollment, 2 and 6 months
Motricity Index
Time frame: Enrollment, 2 and 6 months
Token test
Time frame: Enrollment, 2 and 6 months
The Bells Test
Time frame: Enrollment, 2 and 6 months
Stroop Test
Time frame: Enrollment, 2 and 6 months
Wisconsin Card Sorting test
Time frame: Enrollment, 2 and 6 months
Verbal Fluency
Time frame: Enrollment, 2 and 6 months
Raven's Matrices Test
Time frame: Enrollment, 2 and 6 months
Trail Making A-B Test
Time frame: Enrollment, 2 and 6 months
Center for Epidemiological Studies Depression Scale
Time frame: Enrollment, 2 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram and Rehabilitative treatment in people with Stroke, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Carda, MD (+3903213734844, stefano.carda@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (time frame: Enrollment, 2 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2009.