Effectiveness and tolerability of paroxetine controlled release (CR) in the treatment of major depressive disorder: an open-label, prospective, multi-center trial in Korea.
OBJECTIVE
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 < or = 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.
Pae
Chi-Un
CU
Department of Psychiatry, Kangnam St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.
Bahk
Won-Myong
WM
Jon
Duk-In
DI
Lee
Sang-Yeol
SY
Yoon
Bo-Hyun
BH
Min
Kyung Joon
KJ
D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007723:Korea; D008297:Male; D008875:Middle Aged; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D003692:Delayed-Action Preparations; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors