OBJECTIVE: This open-label, multi-center, non-randomized study evaluated the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia or schizophreniform disorder among Filipino patients.
METHOD: Filipino outpatients with a DSM-IV diagnosis of either schizophrenia or schizophreniform disorder (N = 382) were enrolled in this study. They were treated with an initial dose of 10 mg/day of olanzapine with eventual titration to 5 to 20 mg/day as clinically indicated and were observed for 8 weeks. Efficacy was assessed with the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression - Severity of Illness Scale (CGI-S). Safety was assessed by collecting adverse event reports and checking vital signs.
RESULTS: Statistically significant reductions from baseline to endpoint in both the mean BPRS Total score (from 36.77 +/- 12.12 to 11.43 +/10.39, p0.001) and mean CGI-S score (from 4.64 +/- 0.79 to 2.61 +/- 1.06, p0.001) were seen. The proportion of patients showing 20 percent improvement based on the BPRS Total score was 93.4 percent. Only 51 (13.7 percent) patients reported at least one treatment-emergent adverse event. The most commonly reported were somnolence (3.2 percent), weight loss (2.2 percent), tachycardia (1.3 percent), and headache (1.1 percent).
CONCLUSION: The study clearly demonstrates the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia and schizophreniform disorder among Filipino patients.