To evaluate the efficacy, safety and QOL(quality of life) of blonanserin monotherapy in patients with schizophrenia: open label, multi-center trial.

Koera University Guro Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Subject ages 18 - 65 year old.
•2. Subject meets Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revised(DSM-IV-TR) criteria for a primary diagnosis of schizophrenia.
•3. Meet one or more in the following:
•- Subjects who is first episode schizophrenia,
•- Subjects who has been psychotropic-medication-free at least 2 weeks,
•- Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns
•4. Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.

•1. History of a serious hypersensitivity reaction.or an insufficient therapeutic response to to blonanserin.
•2. Subjects who have received treatment with clozapine or who have received any long-acting antipsychotics injection within 4 weeks prior to screening
•3. Subjects who are unable to complete assessments for evaluating efficacy of blonanserin.
•4. Diagnosis of alcohol or other substance use disorder (except nicotine and caffeine) by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revised(DSM-IV-TR) criteria within 1 year of screening (or at any time during the study)
•5. Subjects who are taking any of the following: adrenalin, azole antifungal agent and HIV protease inhibitor.
•6. Patient with refractory schizophrenia or treatment resistance despite combination treatment of two or more antipsychotics for at least 6 weeks.
•7. History of clinically significant immunological, gastrointestinal, renal, haematological, neurological, cardiovascular, oncological disease.
•8. Pregnant or breast-feeding female patient. (Include female subject who is of reproductive potential gets negative result from an HCG blood test at least 14 days after the first dose of blonanserin has been taken and agrees to remain abstinent or use adequate and reliable contraception throughout the study)

发起方

Koera University Guro Hospital