Clinical trial NCT03523741: Therapeutic Drug Monitoring for Individualized Clozapine Therapy
Official title: A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: genetic polymorphism
pharmacodynamic variability
personalized pharmacotherapy
adverse drug reaction
quality of life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia

Brief summary: The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment

Detailed description: 1. The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
2. On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.

Eligibility criteria: Inclusion Criteria:

1. Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
2. Patients who are 19 years or older
3. Patient who understands the contents of the clinical research and provide their written informed consent forms

Exclusion Criteria:

1. Patients taking a drug that the researcher deems inappropriate before clozapine administration
2. Patients who can not use an appropriate contraceptive method during the study period
3. Patients whom the researcher deemed inappropriate for clinical research participation

Primary outcomes:
measure: Glucose and lipid metabolism abnormality
timeFrame: Change from baseline glucose and lipid profiles on Day 15, and 57
measure: Liver function abnormality
timeFrame: Change from baseline liver function test on Day 15, and 57
measure: Sleeping tendency assessment
timeFrame: Change from baseline sleeping tendency assessment on Day 15, and 57
Secondary outcomes:
measure: Cognitive function assessment
timeFrame: Change from baseline MCCB on Day 57, and 127
measure: Clinical symptom assessment
timeFrame: Change from baseline BPRS on Day 15, and 57
Other outcomes:
measure: Blood clozapine and its metabolite level
timeFrame: On Day 15, and 57 after clozapine dosing
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Sang-In Park, Ph. D.
role: STUDY_CHAIR
References: