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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.
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| Measure | Description | Time Frame |
|---|---|---|
| The change of total score of SHAPS | At baseline | |
| The change of total score of SHAPS | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Clinical Global Impression (CGI)-Severity score | At baseline | |
| Changes of Clinical Global Impression (CGI)-Severity score | At 12 weeks | |
| Proportion of patients having a score of 1 or 2 in CGI-I score |
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Inclusion Criteria:
Exclusion Criteria:
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Department of psychiatry of 25 hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Woo Han, MD, PhD | Department of Psychiatry | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | Busan | South Korea | |||
| Research Site |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| At 12 weeks |
| Proportion of significantly improved patients in SHAPS total score (more than 30%) | At baseline |
| The mean change MADRS total score | At baseline |
| The mean change MADRS total score | At 12 weeks |
| Proportion of significantly improved patients in SHAPS total score (more than 30%) | At 12 weeks |
| Gongju |
| Chungcheongnam-do |
| South Korea |
| Research Site | Daegu | Daegu | South Korea |
| 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 |
| Research Site | Changnyeong | Gyeongsangnam-do | South Korea |
| Research Site | Seoul | Seoul | South Korea |