Effectiveness and tolerability of paroxetine controlled release (CR) in the treatment of major depressive disorder: An open-label, prospective, multi-center trial in Korea

Objectives: This study evaluated the effectiveness and tolerability of paroxetine controlled release (CR) for the treatment of Korean patients with major depressive disorder (MDD) in a naturalistic treatment setting. Methods: One hundred and ninety patients with MDD were enrolled in this study. The Hamilton Depression Rating Scale-17 item (HAMD-17) and Clinical Global Impression-Severity (CGI-S) scores were measured at the baseline (day 0) and at weeks 1, 2, 4, and 8 (endpoint). The primary measure of effectiveness was a change in the mean HAMD-17 scores from the baseline to the endpoint. The secondary effectiveness measures included a decrease in the HAMD-17 scores of 50% or more at the endpoint compared with the baseline and a change in the mean CGI-S scores from the baseline to the endpoint. Remission was defined as a HAMD-17 score ≤ 7 at the endpoint. Results: The HAMD-17 scores decreased by 56.5% (observed difference, OD = -13.3) (t = 26.63, p < 0.0001) from the baseline. The CGI-S scores also decreased by 50.0% (OD = -2.3) (t = 24.47, p < 0.0001). The response and remission rate at the endpoint was 64.2 and 48.4%, respectively. The adverse events were tolerable. No unexpected or serious side effects were observed. Conclusions: Despite the methodological limitations, this study demonstrated that paroxetine CR is effective and tolerable for treating patients with MDD in an East Asian population.