Functional recovery in patients with cerebral infarction MedDRA version: 17.0 Level: PT Classification code 10008118 Term: Cerebral infarction System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Citalopram Teva-Rimafar
Product Name: Citalopram
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CITALOPRAM
CAS Number: 59729-33-8
Concentration unit: mg milligram(s)
Concentration
Sponsors
Fundació Privada Hospital Asil de Granollers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with a first cerebral infarction with NIHSS 5-20 points ? Patients without aphasia to avoid their interference in the assessment of depression and cognitive impairment ? Patients with independent functional status previous to the cerebral infarction (mRS =65 years) yes F.1.3.1 Number of subjects for this age range 168
Exclusion criteria
Exclusion criteria: ? Patients with prior myocardial infarction or cerebral hemorrhage ? Patients with AIT ? Patients with aphasia ? History of prior cognitive impairment or depressive syndrome ? Patients with non-independent prior functional status mRS greater than or equal to 3 ? Underlying disease with life expectancy of less than one year. ? Patient pretreatment with levodopa, an antidepressant or neuroleptic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate at 12 months if treatment with drugs that increase the release of neurotransmitters in acute cerebral ischemia improves functional outcome compared with conventional treatment.;Primary end point(s): Functional status, neurological severity, the degree of depression and cognitive impairment in each group compared to the control will be compared.;Timepoint(s) of evaluation of this end point: 12 months;Secondary Objective: Secondary objectives assessed at medical discharge, 3, 6 and 12 months ? Compare the functional improvement with modified Rankin scale in each treatment group. ? Compare the neurological severity with the NIHSS scale in each group Secondary objectives assessed at medical discharge, 6 and 12 months ? Compare the improvement in depression measured with the Montgomery-Åsberg scale among the three groups ? Compare the cognitive improvement with the Mini Mental scale among the three groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are not secondary end points;Timepoint(s) of evaluation of this end point: Non Applicable | — |
Countries
Spain
Contacts
Public ContactUnitat de Recerca i Innovació
Fundació Privada Hospital Asil de Granollers
Outcome results
None listed