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Effect of Serotonin and Levodopa in Ischemic Stroke (SELEIS)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
placebo
citalopram
sinemet plus
Sponsored by
Hospital de Granollers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients with a first stroke with NIHSS 5-20 points

    • Patients without aphasia to avoid interference in the assessment of depression and cognitive impairment
    • Patients with independent functional status prior to stroke (mRS <3)
    • Patients without prior cognitive impairment or depressive syndrome assessed by medical history with the patient and family.
    • The assigned treatment initiated within the first five days of stroke

Exclusion Criteria:

  • • Patients with prior myocardial or cerebral hemorrhage

    • Patients with TIA
    • Patients with aphasia
    • History of cognitive impairment or prior depressive syndrome
    • Patients with no independent functional status mRS greater than or equal to 3
    • Underlying disease hopefully less than one year of life.
    • Patient pre-treatment with levodopa, an antidepressant or neuroleptic.

Sites / Locations

  • Granollers General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

citalopram 20 mg

sinemet plus 100 mg

Sinemet Plus + citalopram group

Arm Description

In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.

In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.

In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.

In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.

Outcomes

Primary Outcome Measures

Rankin Scale

Secondary Outcome Measures

Full Information

First Posted
March 6, 2015
Last Updated
November 25, 2019
Sponsor
Hospital de Granollers
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1. Study Identification

Unique Protocol Identification Number
NCT02386475
Brief Title
Effect of Serotonin and Levodopa in Ischemic Stroke
Acronym
SELEIS
Official Title
Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Granollers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.
Detailed Description
Methods. Evaluate 240 consecutive patients with a first ischemic stroke with NIHSS 5-20 without aphasia and with a previous independent functional status (mRS <3). Patients will be randomized into four arms: 1) control group, 2) treatment with citalopram 20 mg / day, 3) group levodopa (sinemet plus)100 mg / day, 4) group levodopa (sinemet plus) 100 mg / day + citalopram 20 mg / day. The treatment begins within the first 5 days of stroke and is maintained for 6 months. All patients will be treated according to current guidelines for secondary prevention. We will assess the following variables: demographic, vascular risk factors, etiologic subtypes according to TOAST criteria, neurologic deficit with the NIHSS scale, cognitive assessment with Minimental scale and functional status with scale modified Rankin at discharge, 3, 6 and 12 months, Symbol Digit Modalities Test (SDMT), GDS-15 Geriatric Depression Scale, Logical memory of WMS-IV . The cognitive assessment and motor functional status will be evaluated by a neuropsychologist and neurologist blinded to treatment assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Arm Title
citalopram 20 mg
Arm Type
Active Comparator
Arm Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Arm Title
sinemet plus 100 mg
Arm Type
Active Comparator
Arm Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Arm Title
Sinemet Plus + citalopram group
Arm Type
Active Comparator
Arm Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
control group
Intervention Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Intervention Type
Drug
Intervention Name(s)
citalopram
Other Intervention Name(s)
citalopram group
Intervention Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Intervention Type
Drug
Intervention Name(s)
sinemet plus
Other Intervention Name(s)
sinemet group
Intervention Description
In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
Primary Outcome Measure Information:
Title
Rankin Scale
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients with a first stroke with NIHSS 5-20 points Patients without aphasia to avoid interference in the assessment of depression and cognitive impairment Patients with independent functional status prior to stroke (mRS <3) Patients without prior cognitive impairment or depressive syndrome assessed by medical history with the patient and family. The assigned treatment initiated within the first five days of stroke Exclusion Criteria: • Patients with prior myocardial or cerebral hemorrhage Patients with TIA Patients with aphasia History of cognitive impairment or prior depressive syndrome Patients with no independent functional status mRS greater than or equal to 3 Underlying disease hopefully less than one year of life. Patient pre-treatment with levodopa, an antidepressant or neuroleptic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Cocho
Organizational Affiliation
Hospital de Granollers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Granollers General Hospital
City
Granollers
State/Province
Barcelnoa
ZIP/Postal Code
08402
Country
Spain

12. IPD Sharing Statement

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Effect of Serotonin and Levodopa in Ischemic Stroke

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