The populations of the study will be: -schizophrenic patients according to DSM IV-TR diagnosis -have to present the first symptoms of the schizophrenia for at least one year -have to present an exacerbation of the disease but without risk of suicide -must not have clinically significant disease or biological/ECG abnormality which might create a risk for the patient, obscure the effects of study treatment or interfere with drug absorption, metabolism or excretion
Conditions
Sponsors
Neuro3d
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Schizophrenic patients according to DSM IV-TR diagnosis and presenting two of the following manifestations: 1)delusions; 2)hallucinations; 3)disorganised speech (e.g., frequent derailment or incoherence); 4)grossly disorganised or catatonic behaviour; 5)negative symptoms, i.e., affective flattening, alogia, or avolition; -Patients presenting symptoms for at least one year. -Patients presenting an exacerbation: minimum total score of 60 on PANSS (score higher or equal to 60) and a score of 4 or more on any two of the following three items of positive symptoms scale: P1 Delusions P3 Hallucionatory behaviou P6 Suspiciousness/ persecution 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: -Patients who did not respond to 3 different anti-psychotic treatments at recommended doses for at least 3 months each; -Clinically significant laboratory abnormality or disease which, in the opinion of the investigator, might create risk for the patient, obscure the effects of study treatment, or interfere with drug absorption, metabolism or excretion; -Any patient having taken olanzapine within the last year -Serious risk of suicide evaluated according to the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of ocaperidone versus olanzapine on weight in schizophrenic patients;Secondary Objective: To assess PANSS scores (global and positive and negative subscores) and BPRS (item scores) versus olanzapine To assess the neurocognitive performances versus olanzapine To assess the clinical and biological tolerability and the safety of ocaperidone and the safety of ocaperidone and olanzapine in schizophrenic patients;Primary end point(s): Change from baseline in the weight of the subject at the last measured point | — |
Countries
Latvia
Outcome results
None listed