Schizophrenia
Conditions
Sponsors
Sumitomo Dainippon Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria - Patients who are aged 18 years or older at informed consent - Patient understands the objectives and procedures of the study and who provide written voluntarily consent to participate in the study, etc.
Exclusion criteria
Exclusion criteria: - Patients who fall under a contraindication listed in the LONASEN package insert - Patients with Parkinson disease - Patients who previously received blonanserin, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The primary endpoint is the change in PANSS total score from baseline at Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Change in PANSS subscale scores from baseline at Week 6 - Change in PANSS five-factor modelNote scores from baseline at Week 6 - Change in Clinical Global Impressions - Severity of Illness (CGI-S) score from baseline at Week 6 - Change in PANSS total score from the last evaluation before the initial application of DSP-5423P at each visit - Change in PANSS subscales from the last evaluation before the initial application of DSP-5423P at each visit - Change in PANSS five-factor models from the last evaluation before the initial application of DSP-5423P at each visit - Proportion of subjects who achieve a response, defined as 20% or greater improvement from baseline in PANSS total score at Week 6 | — |
Countries
Asia except Japan, Japan, Russia, Ukraine
Outcome results
None listed