Subjects and
Methods: The sample consisted of 60 subjects, age ranged was between 18-60
years, both genders, who met the criteria for the diagnosis various types of
schizophrenia, according to ICD-10 (International Statistical Classification of
Diseases). They were enrolled in the study as outpatient and inpatient setting.
All subjects signed informed consent before entering into this study which had
been conducted at the Psychiatric Clinic, University Clinical Center Sarajevo.
Study was designed for 8-week, open-label, flexible-dose observational study.
The subjects had to have a total score >-40 on Positive and Negative scale –two
parts of the Positive and Negative Syndrome Scale (PANSS), and to be able to
discontinue current antipsychotic medications. The primary efficacy parameter
was the percent of score difference between baseline and week 8 of therapy
on two above–mentioned PANSS subscales. The difference was considered
as significant improvement if decrease from the baseline was 20% or more.
The secondary efficacy parameter was subjective clinical evaluation of efficacy
with five possible answers: very good, good, moderate, not satisfactory, not
possible to evaluate. It was measured at the end of observational period by the
investigator