The GiSAS study is a multi-centre randomized clinical trial that will involve about 80
italian community psychiatric services in Italy and will recruit 800 patients affected by
In a sample of schizophrenic outpatients, it is hypothesized that there are significant
differences in the overall tolerability and effectiveness of aripiprazole, olanzapine and
haloperidol at 12 months.
It is a pragmatic trial. Thus, participants are selected to represent a broad range of
"real-world" patients, all treatment medications are non-blinded and after randomization, the
assigned drugs will be prescribed according to usual care practice.
The measure for effectiveness is retention of patients on the assigned treatment. The measure
for tolerability is the onset of metabolic syndrome.