Effect of Serotonin and Levodopa in Ischemic Stroke "SELEIS"

Recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • citalopram (Celexa)Drug
    Other Names: citalopram group
    Intervention Desc: 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 1: Kind: Experimental
    Label: citalopram 20 mg
    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 2: Kind: Experimental
    Label: Sinemet Plus + citalopram group
    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.
  • Placebo Drug
    Intervention Desc: 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 1: Kind: Experimental
    Label: Placebo
    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.
  • Sinemet plus Drug
    Other Names: sinemet group
    Intervention Desc: 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 1: Kind: Experimental
    Label: sinemet plus 100 mg
    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 2: Kind: Experimental
    Label: Sinemet Plus + citalopram group
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Rankin Scale 12 months Yes

Sponsors