EFFECT OF SEROTONIN AND LEVODOPA FUNCTIONAL RECOVERY IN PATIENTS WITH CEREBRAL INFARCTIO

• Conditions: Functional recovery in patients with cerebral infarction; MedDRA version: 17.0Level: PTClassification code 10008118Term: Cerebral infarctionSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000846-32-ES
• Lead Sponsor: Fundació Privada Hospital Asil de Granollers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-22
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <3)
? Patients without cognitive impairment or prior depressive syndrome assessed by medical history with the patient and family.
? The assigned treatment was initiated within the first 5 days of cerebral infarction
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>? Compare the functional improvement with modified Rankin scale in each treatment group. <br>? Compare the neurological severity with the NIHSS scale in each group <br><br>Secondary objectives assessed at medical discharge, 6 and 12 months <br>? Compare the improvement in depression measured with the Montgomery-Åsberg scale among the three groups <br>? Compare the cognitive improvement with the Mini Mental scale among the three groups

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): There are not secondary end points;Timepoint(s) of evaluation of this end point: Non Applicable