Schizophrenia
Conditions
Interventions
Trade Name: Leponex
Pharmaceutical Form: Pastille
Sponsors
Fundación Cerebro y Mente
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Very obvious estresors related to the onset on psychoses Any other axis I process Cranial traumatism with loss of conscioussness longer than one minute Sustance abuse Contraindication for magnetic resonance imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: ;Primary end point(s): Two yerars of treatment | — |
Countries
Spain
Outcome results
None listed