Therapeutic Drug Monitoring for Individualized Clozapine Therapy

• Conditions: Schizophrenia

• Registration Number: NCT03523741
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Study Start: 2018-06-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose and lipid metabolism abnormality	Change from baseline glucose and lipid profiles on Day 15, and 57	Change from baseline glucose and lipid profiles after clozapine administration
Sleeping tendency assessment	Change from baseline sleeping tendency assessment on Day 15, and 57	Epworth sleepiness scale (ESS).; * ESS is comprised of eight questions, each asking about the subject's likelihood of dozing off or falling asleep in a particular situation that is commonly met in daily life.; * Each ESS item score measures a particular "situational sleep propensity", and respondents use a four-point scale from 0 (no chance of dozing/falling asleep) to 3 (high chance of dozing/falling asleep) for each of the eight questions.; * The sum of eight item scores (the total ESS score) measures the subject's average sleep propensity across those different situations in daily life. A total ESS score of 16-24 points indicates severe excessive daytime sleepiness.
Liver function abnormality	Change from baseline liver function test on Day 15, and 57	Change from baseline liver function test

Secondary Outcome Measures

Name	Time	Method
Cognitive function assessment	Change from baseline MCCB on Day 57, and 127	MCCB (MATRICS Consensus Cognitive Battery).
Clinical symptom assessment	Change from baseline BPRS on Day 15, and 57	Brief Psychiatric Rating Scale (BPRS).; * BPRS is a 24-item scale that measures psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour.; * Each symptom is rated on a scale from 1(not present) to 7(extremely severe).; * The sum of all 24 items is then calculated to a maximum score of 168. The higher the score, the more psychiatrically impaired the patient is.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of