CLOZAPINA EN PRIMEROS BROTES DE ESQUIZOFRENIA COMO POSIBLE TRATAMIENTO PREVENTIVO DEL DETERIORO CEREBRAL Y CLINICO

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: Leponex Pharmaceutical Form: Pastille CONDITION: Schizophrenia PRIMARY OUTCOME: Main Objective: Basical and clinical data suggest its potential for the treatment in early stages of the illness, when the deterioration rate can be faster. In this project our aim is to confirm that clozapine may limit the rate of gray matter loss and functional deterioration in a greater degree than any other antipsychotic. This hypothesis is based upon the likely hyper‐glutamatergic cortical state in schizophrenia, with possible toxic consequences.; We pretend to assess 60 first episodes of schizophrenia, that will be followed for 2 years using clinical data and magnetic resonance (volumetric and spectroscopic, determining the levels of NAA and glutamate). We will also acquire neuropsychological related to prefrontal functions. A group of 30 subjects will be treated with clozapine and the other 30 patients with risperidone. The outcome in clinical, neuropsychological and cerebral parameters will be compared between the patients groups and with a healthy control group.; Primary end point(s): Two yerars of treatment Secondary Objective: INCLUSION CRITERIA: Schizophrenia (DSM‐IV), with a duration lesser than one year, ‐ ‐Potential clinical benefit from the drugs oninvestigation. ‐ Informed consent form the patient and family 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: db0a517e5e7efd4bde0f586e72f6d2e9935d5399
First added on: Aug 21, 2024