This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.
Study Type
OBSERVATIONAL
Enrollment
231
Research Site
Busan, Busan, South Korea
Research Site
Gongju, Chungcheongnam-do, South Korea
Research Site
Daegu, Daegu, South Korea
The change of total score of SHAPS
Time frame: At baseline
The change of total score of SHAPS
Time frame: At 12 weeks
Changes of Clinical Global Impression (CGI)-Severity score
Time frame: At baseline
Changes of Clinical Global Impression (CGI)-Severity score
Time frame: At 12 weeks
Proportion of patients having a score of 1 or 2 in CGI-I score
Time frame: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Time frame: At baseline
The mean change MADRS total score
Time frame: At baseline
The mean change MADRS total score
Time frame: At 12 weeks
Proportion of significantly improved patients in SHAPS total score (more than 30%)
Time frame: At 12 weeks
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Research Site
Daejeon, Daejeon, South Korea
Research Site
Chuncheon, Gangwon-do, South Korea
Research Site
Anyang-si, Gyeonggi-do, South Korea
Research Site
Bucheon-si, Gyeonggi-do, South Korea
Research Site
Goyang-si, Gyeonggi-do, South Korea
Research Site
Yongin-si, Gyeonggi-do, South Korea
Research Site
Gyeongju, Gyeongsangbuk-do, South Korea
...and 2 more locations