Schizophrenia
Conditions
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with a diagnosis of schizophrenia as defined by DSM-5. 2)Written consent can be obtained from the patient. 3)Patient's condition is confirmed to be the acute exacerbation period of schizophrenia by the investigator or sub-investigator. etc.
Exclusion criteria
Exclusion criteria: 1)Total PANSS score has decreased by 20% or more from screening to baseline. 2)Patients of treatment-refractory. 3)Patients with a history or a complication of organic brain disorder. 4)Patients with a diagnosis of mental retardation or a personality disorder. 5)Patients with a risk of taking medicine compliance by the investigator or sub-investigator. 6)At screening, HbA1c (NGSP) level is 8.4% or higher. 7)Patients undergoing drug therapy complicated by uncontrolled liver disease, kidney disease, respiratory disease, gastrointestinal disease, hematologic disease, endocrine disease, metabolic disease, or cranial nerve disease or other clinically significant progressive physical disease. 8)Patients with a serious cardiovascular disorders. 9)Patients with a risk of QT interval extension. 10)Patients with a Fridericia's corrected QT interval (QTcF) of 450 msec or longer. 11)Patients with a history of malignant syndrome. 12)Patients with a complication of Parkinson's disease. 13)Patients with a Tardive dyskinesia. 14)Patients with a risk of suicide as determined by the investigator or sub-investigator. 15)Female patients who are pregnant, nursing, or potentially pregnant, who wishes to become pregnant, or a male patients whose partner wish to become pregnant. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy PANSS total score. Change in PANSS total score from baseline to the end of treatment (at Week 6 of treatment phase or Discontinuuation.) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy PANSS subscore. Clinical Global Impression-Severity of illness (CGI-S). Clinical Global Impression-Global Improvement (CGI-I). Change in PANSS subscore from baseline, and the PANSS responder rate. Change in CGI-S score. CGI-I response rate. Adverse events. Incidence of adverse events. | — |
Countries
Japan
Outcome results
None listed