Effect of Serotonin and Levodopa in Ischemic Stroke (SELEIS)

November 25, 2019 updated by: Hospital de Granollers

Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelnoa
      • Granollers, Barcelnoa, Spain, 08402
        • Granollers General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Other: placebo
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.
Other Names:
  • control group
Active Comparator: citalopram 20 mg
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.
Drug: citalopram
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.
Other Names:
  • citalopram group
Active Comparator: sinemet plus 100 mg
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.
Drug: sinemet plus
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.
Other Names:
  • sinemet group
Active Comparator: Sinemet Plus + citalopram group
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.
Drug: citalopram
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.
Other Names:
  • citalopram group
Drug: sinemet plus
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.
Other Names:
  • sinemet group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rankin Scale
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Granollers

Investigators

  • Principal Investigator: Dolores Cocho, Hospital de Granollers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELEIS
  • 2014-000846-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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