Placebo-controlled double-blind comparative study of ME2112 in patients with acute exacerbation of schizophrenia (Phase III)

Meiji Seika Pharma Co., Ltd.0 个研究点目标入组 400 人开始时间: 2015年2月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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.

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