Clinical trial NCT02386475: Effect of Serotonin and Levodopa in Ischemic Stroke
Official title: Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Rankin Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Granollers General Hospital
state: Barcelnoa
Study officials:
affiliation: Hospital de Granollers
name: Dolores Cocho
role: PRINCIPAL_INVESTIGATOR
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