Skip to main content
OpenTrials
Completed

NCT Number: NCT02386475

Effect of Serotonin and Levodopa in Ischemic Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Granollers General Hospital

Granollers, Barcelnoa, 08402, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

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

Citalopram

Drug

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

sinemet plus

Drug

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

Primary outcomes

  1. Rankin Scale

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Registry information

Official study title

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

Acronym: SELEIS

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Mar 12, 2015
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.