This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the
efficacy of controlled-release (CR) formulation of paroxetine orally administered to
patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day
(initial dose level, 12. 5 or 25 mg/day) once daily after evening meal for 8 weeks based on
the decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety
based on adverse events, laboratory data and vital signs, and to describe the efficacy and
safety of immediate release (IR) formulation of paroxetine.
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
GSK Investigational Site, Aichi 453-0015, Japan
GSK Investigational Site, Aichi 468-0045, Japan
GSK Investigational Site, Aichi 479-0837, Japan
GSK Investigational Site, Chiba 272-0133, Japan
GSK Investigational Site, Fukuoka 802-0084, Japan
GSK Investigational Site, Fukuoka 802-8533, Japan
GSK Investigational Site, Fukuoka 810-0001, Japan
GSK Investigational Site, Fukuoka 810-0022, Japan
GSK Investigational Site, Fukuoka 811-0121, Japan
GSK Investigational Site, Fukuoka 815-0041, Japan
GSK Investigational Site, Fukuoka 819-0167, Japan
GSK Investigational Site, Gunma 379-0115, Japan
GSK Investigational Site, Hokkaido 060-0003, Japan
GSK Investigational Site, Hokkaido 060-0042, Japan
GSK Investigational Site, Hokkaido 063-0804, Japan
GSK Investigational Site, Hyogo 651-0097, Japan
GSK Investigational Site, Hyogo 657-0846, Japan
GSK Investigational Site, Hyogo 660-0882, Japan
GSK Investigational Site, Ibaraki 311-3193, Japan
GSK Investigational Site, Kanagawa 220-0004, Japan
GSK Investigational Site, Kanagawa 221-0835, Japan
GSK Investigational Site, Kanagawa 223-0052, Japan
GSK Investigational Site, Kanagawa 231-0023, Japan
GSK Investigational Site, Kanagawa 238-0042, Japan
GSK Investigational Site, Kanagawa 244-0816, Japan
GSK Investigational Site, Kanagawa 251-0055, Japan
GSK Investigational Site, Kumamoto 861-8002, Japan
GSK Investigational Site, Kyoto 616-8421, Japan
GSK Investigational Site, Nagano 390-0303, Japan
GSK Investigational Site, Nagano 399-8695, Japan
GSK Investigational Site, Osaka 530-0041, Japan
GSK Investigational Site, Osaka 569-7711, Japan
GSK Investigational Site, Osaka 582-0025, Japan
GSK Investigational Site, Osaka 589-0011, Japan
GSK Investigational Site, Saga 840-0816, Japan
GSK Investigational Site, Saga 843-0023, Japan
GSK Investigational Site, Saitama 331-0081, Japan
GSK Investigational Site, Saitama 332-0012, Japan
GSK Investigational Site, Saitama 350-0046, Japan
GSK Investigational Site, Saitama 366-0824, Japan
GSK Investigational Site, Tochigi 321-0953, Japan
GSK Investigational Site, Tokyo 135-0061, Japan
GSK Investigational Site, Tokyo 107-0052, Japan
GSK Investigational Site, Tokyo 167-0051, Japan
GSK Investigational Site, Tokyo 141-0021, Japan
GSK Investigational Site, Tokyo 142-0051, Japan
GSK Investigational Site, Tokyo 151-0053, Japan
GSK Investigational Site, Tokyo 152-0012, Japan
GSK Investigational Site, Tokyo 154-0004, Japan
GSK Investigational Site, Tokyo 165-0033, Japan
GSK Investigational Site, Tokyo 166-0003, Japan
GSK Investigational Site, Tokyo 167-0042, Japan
GSK Investigational Site, Tokyo 170-0002, Japan
GSK Investigational Site, Tokyo 173-0037, Japan
GSK Investigational Site, Tokyo 180-0005, Japan
GSK Investigational Site, Tokyo 192-0082, Japan
GSK Investigational Site, Tokyo 100-0006, Japan
GSK Investigational Site, Tottori 682-0023, Japan
GSK Investigational Site, Gwangju 501-757, Korea, Republic of
GSK Investigational Site, Seoul 110-744, Korea, Republic of
GSK Investigational Site, Seoul 156-707, Korea, Republic of
GSK Investigational Site, Seoul 135-710, Korea, Republic of
GSK Investigational Site, Seoul 136-705, Korea, Republic of
GSK Investigational Site, Seoul 137-701, Korea, Republic of
GSK Investigational Site, Seoul 138-736, Korea, Republic of
GSK Investigational Site, Seoul 150-713, Korea, Republic of
GSK Investigational Site, Seoul 110-746, Korea, Republic of
Higuchi T, Hong JP, Jung HY, Watanabe Y, Kunitomi T, Kamijima K. Paroxetine controlled-release formulation in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled study in Japan and Korea. Psychiatry Clin Neurosci. 2011 Dec;65(7):655-63. doi: 10.1111/j.1440-1819.2011.02243.x. Epub 2011 Sep 6.