Safety of quetiapine fumarate extended release in the treatment of Korean patients with acute schizophrenia
Human Psychopharmacology: Clinical and Experimental, 07/05/2012
Lee JG et al. – In this study of Korean patients with acute schizophrenia, quetiapine extended release showed clinical efficacy and relatively good tolerability.Methods
- This was an 8–week, multi–center, open–label, non–comparative study to evaluate the efficacy and safety of quetiapine fumarate XR at a daily dose of 400–800 mg.
- Changes in total scores on the Positive and Negative Syndrome Scale (PANSS) from baseline to week 8 were analyzed to evaluate the efficacy of quetiapine XR.
- Additionally, the Clinical Global Impression scale and the Montgomery–Asberg Depression Rating Scale were administered.
- The mean change in PANSS total scores was –26.8, and the mean PANSS total score at the endpoint was significantly lower than that at baseline.
- The mean PANSS positive score, negative score, and general score showed statistically significant reductions at the end of the study.
- Statistically significant changes were also observed in Clinical Global Impression–Severity and Montgomery–Asberg Depression Rating Scale scores.
- The most common treatment–related adverse events in the group receiving quetiapine XR were sedation (10.6%) and constipation (9.6%).