A clinical trial to investigate the factors affecting adverse drug reactions and clinical efficacy of clozapine in Korea
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003052
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
?Patients who can provide their written informed consents according to GCP and related regulations
?Men and women over the age of 19
?Patients who are diagnosed as schizophrenia spectrum disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and expected to use clozapine for more than 57 days(More than 14 days after the last dose of clozapine in patients who previously used clozapine)
?Patients who understand the contents of the clinical research explanations and have given written informed consents
? Patients who took a drug that the investigator deemed inappropriate before clozapine administration within 2 weeks before screening. (which may be acceptable if the investigator considers to have no effect on pharmacokinetics or safety of the study drug)
? Patients who are planning a pregnancy or who can not use approved methods for contraception during the study period
? Patients who are considered to be inappropriate for study participation by the investigator based on other reasons including clinical laboratory test results
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose and lipid metabolism abnormality;Liver function abnormality;Sleeping tendency assessment
- Secondary Outcome Measures
Name Time Method Cognitive function assessment (MCCB (MATRICS Consensus Cognitive Battery));Clinical symptom assessment (Brief Psychiatric Rating Scale (BPRS));Blood clozapine and its metabolite level