Therapeutic Drug Monitoring for Individualized Clozapine Therapy

Schizophrenia Clinical Trial

Official title:

A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523741
• Other study ID #: CLZ_01
• Status: Recruiting
• Start date: June 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: Euitae Kim, Ph. D.
• Phone: +82-31-787-7435
• Email: euitae.kim[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Clozapine
Clozapine is administered orally according to individual prescribed dosing regimens.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood clozapine and its metabolite level	Relationship between occurrence of clozapine adverse drug reactions and clozapine blood concentration	On Day 15, and 57 after clozapine dosing
Primary	Glucose and lipid metabolism abnormality	Change from baseline glucose and lipid profiles after clozapine administration	Change from baseline glucose and lipid profiles on Day 15, and 57
Primary	Liver function abnormality	Change from baseline liver function test	Change from baseline liver function test on Day 15, and 57
Primary	Sleeping tendency assessment	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.	Change from baseline sleeping tendency assessment on Day 15, and 57
Secondary	Cognitive function assessment	MCCB (MATRICS Consensus Cognitive Battery).	Change from baseline MCCB on Day 57, and 127
Secondary	Clinical symptom assessment	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.	Change from baseline BPRS on Day 15, and 57