Observational study of schizophrenia outpatients in Central and Eastern Europe: 3- And 6-month efficacy and safety results

Tamar Treuer, Martin Dossenbach, Joanna Meder, Erik Herman, Jan Pecenak, Rok Tavar, Eszter Banki, Mihai Tatu, Dalia Peciukaitiene, Istvan Bitter

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2 Citations (Scopus)


Objectives: Comparative outcomes associated with antipsychotic treatment of outpatients with schizophrenia and changes in clinical status over the first 6 months of treatment in participating patients from Central and Eastern Europe (CEE) are presented. Methods: The Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) study is a 3-year, prospective, observational study of health outcomes associated with antipsychotic medication in outpatients treated for schizophrenia. This article reports on the 6-month interim results in the region of CEE (n=2252). Subjects aged > 18 years and undergoing treatment for schizophrenia were enrolled if, at the discretion of the treating psychiatrist, they initiated or changed antipsychotic medication. For primary analyses, two treatment groups were established; olanzapine and 'other antipsychotics'(non- olanzapine including risperidone) treatment. Subanalysis of olanzapine versus risperidone groups was also done as secondary comparison. Measures of treatment effectiveness (Clinical Global Impression of Severity, CGI-S; overall, positive, negative, cognitive and depressive domains), safety - incidence of extrapiramydal symptoms (EPS), tardive dyskinesia (TD), side effects (sexual dysfunction and weight change) - were taken at baseline, and at 3 and 6 months afier after enrolment. Results: Olanzapine (51%) and risperidone (18.4%) were the most frequently prescribed antipsychotics in this study. Coprescription of anticholinergics was at least 3 times more frequent for risperidone-treated patients compared to those treated with olanzapine on the 6-month visit. Olanzapine was more efficacious in the treatment of overall symptom severity (CGI-s) than risperidone or 'other antipsychotics'. In all other symptom domains (CGI-S), patients responded significantly better to treatment with olanzapine than with 'other antipsychotics'. EPS significantly declined over the treatment period for patients taking olanzapine. Compared to patients on 'other antipsychotics' significantly fewer patients receiving olanzapine therapy developed TD post-baseline. In addition, more patients on olanzapine therapy presented with a remission of TD symptoms after 3- and 6-month treatment compared to patients on 'other antipsychotics' and risperidone. The prevalence of side effects associated with sexual function (loss of libido, impotence/sexual dysfunction) was reduced with olanzapine treatment compared to 'other antipsychotics' or risperidone. Compared to the patients taking 'other antipsychotics' or risperidone, fewer patients developed loss of libido, and more patients recovered from these symptoms within 6 months of olanzapine treatment. Similaly, fewer olanzapine patients suffered from impotence/sexual dysfunction over the first 3 months of treatment, and more patients had recovered from pre-existing symptoms after 6 months than those taking 'other antipsychotics' or risperidone. Menstrual disturbances were less common in women after 3 and 6 months of olanzapine therapy compared to female patients taking 'other antipsychotics'. Patients taking olanzapine were significantly more likely to gain > 7% of their baseline weight over a 6-month period Conclusions: Initial 3- and 6-month findings included in this progress report indicated that patients treated with olanzapine showed greater improvements in terms of therapeutic efficacy, and that it was associated with a more favorable safety profile compared to patients treated with 'other antipsychotics' or risperidone.

Original languageEnglish
Pages (from-to)49-57
Number of pages9
JournalSocijalna Psihijatrija
Issue number2
Publication statusPublished - Jun 2004



  • Atypical antipsychotics
  • Conventional neuroleptics
  • Observational study
  • Olanzapine
  • Risperidone
  • Schizophrenia
  • Treatment patterns

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Treuer, T., Dossenbach, M., Meder, J., Herman, E., Pecenak, J., Tavar, R., Banki, E., Tatu, M., Peciukaitiene, D., & Bitter, I. (2004). Observational study of schizophrenia outpatients in Central and Eastern Europe: 3- And 6-month efficacy and safety results. Socijalna Psihijatrija, 32(2), 49-57.