KCT0003052
Recruiting
未知
A clinical trial to investigate the factors affecting adverse drug reactions and clinical efficacy of clozapine in Korean
ConditionsMental and behavioral disorders
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Mental and behavioral disorders
- Sponsor
- Kyung Hee University
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified
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