None listed
Conditions
Interventions
Drug : All patients will receive blonanserin 4~24mg per day for 24 weeks.
The Start Dose is 4~8mg/day, the maximum daily dose is available up to 24mg.
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of PANSS(Positive and Negative Syndrome Scale) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of CGI(Clinical Global Impression), K-CDSS(The Korean Version of the Calgary Depression Scale for Schizophrenia);Safety (The UKU Side Effect Rating Scale, Metabolic parameters, physical examination, vital signs, clinical laboratory test and EKG test);Quality of Life (KmSWN-10: Scale to Measure Subjective Well-Being Under Neuroleptic Treatment) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Hee Yi
Koera University Guro Hospital
Outcome results
None listed