OBJECTIVES: Evaluation of HRQOL has gained increasing importance in assessing the impact of mental health policies and the introduction of new neuroleptic drugs. Quetiapine, a new antipsychotic medication with improved effectiveness, safety and tolerability profile was introduced in Greece in 2001. The objective of this study is to assess the HRQOL impact of quetiapine-based treatment to patients with schizophrenia using a combined set of outcome measures based on a) psychopathology, b) HRQOL profiles and c) disability scales. METHODS: An open label, 52-week follow-up study of 170 patients is being conducted in 8 psychiatric hospitals across Greece. Enrolled patients were diagnosed with mild to moderate schizophrenia (according to the DSM-IV), aged 18-65, hospitalized or outpatients, newly diagnosed or in acute exacerbation and assessed at 4 scheduled visits (baseline, 3-6-12 months). Outcome measures employed combine psychopathology scales (PANSS, CGI), HRQOL profiles (SF-36, EQ-5D, QLS) and disability indices (WHO-DAS). All measures are psychometrically and culturally adapted. The results of 6-month follow-up period are presented in this analysis. RESULTS: Compared to baseline, statistically significant improvements were seen at 6 months in PANSS general psychopathology (48.6 vs. 33.3), positive (23.8 vs.15.2) and negative symptom (24.3 vs. 17.8) mean scores (p <0.001). CGI scores improved from mean level of 5,1 (baseline) to 4,1 (p <0.001). All SF-36 dimension scores, especially Role Physical and Role Emotional were significantly improved (p <0.001). All EQ-5D dimensions were improved but only the mobility dimension and VAS scores showed statistically significant improvement (p <0.001). Total and subscale QLS scores were significantly improved except the Instrumental Role Subscale Score (p <0.001). A statistically significant improvement was shown on all WHO-DAS-II dimensions (p <0.001). CONCLUSIONS: After 6 months follow-up, quetiapine-treated patients showed a considerable, significant improvement in terms of psychopathology and HRQOL. The combined approach provides for a comprehensive assessment of HRQOL impact of new antipsychotic medications.