Effect of Serotonin and Levodopa in Ischemic Stroke (SELEIS)

Hospital de Granollers

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Drug: citalopram; Drug: sinemet plus; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02386475

SELEIS

2014-000846-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator 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.

Treatment:

Other: placebo

citalopram 20 mg

Active Comparator 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.

Treatment:

Drug: citalopram

sinemet plus 100 mg

Active Comparator 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.

Treatment:

Drug: sinemet plus

Sinemet Plus + citalopram group

Active Comparator 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.

Treatment:

Drug: sinemet plus

Drug: citalopram