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Effect of Serotonin and Levodopa in Ischemic Stroke (SELEIS)

This study is currently recruiting participants.
Verified August 2017 by Hospital de Granollers
Sponsor:
ClinicalTrials.gov Identifier:
NCT02386475
First Posted: March 12, 2015
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital de Granollers
  Purpose
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.

Condition Intervention Phase
Stroke Other: placebo Drug: citalopram Drug: sinemet plus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction

Resource links provided by NLM:


Further study details as provided by Hospital de Granollers:

Primary Outcome Measures:
  • Rankin Scale [ Time Frame: 12 months ]

Estimated Enrollment: 240
Study Start Date: January 2015
Estimated Study Completion Date: December 30, 2018
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: sinemet group

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386475


Contacts
Contact: Dolores Cocho 938425000 dcocho@fhag.es

Locations
Spain
Granollers General Hospital Recruiting
Granollers, Barcelnoa, Spain, 08402
Contact: Dolores Cocho, M.D.    938425000    dcocho@fhag.es   
Contact: diana navarro, Ph. D.    938425000    diananavarro@fhag.es   
Principal Investigator: Dolores Cocho, M.D.         
Sponsors and Collaborators
Hospital de Granollers
Investigators
Principal Investigator: Dolores Cocho Hospital de Granollers
  More Information

Publications:

Responsible Party: Hospital de Granollers
ClinicalTrials.gov Identifier: NCT02386475     History of Changes
Other Study ID Numbers: SELEIS
2014-000846-32 ( EudraCT Number )
First Submitted: March 6, 2015
First Posted: March 12, 2015
Last Update Posted: August 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Levodopa
Dexetimide
Carbidopa, levodopa drug combination
Carbidopa
Serotonin
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Receptor Agonists
Serotonin Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents