Therapeutic Drug Monitoring for Individualized Clozapine Therapy

NCT03523741 | Unknown DMC

• 1 other identifier: CLZ_01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

genetic polymorphism; pharmacodynamic variability; personalized pharmacotherapy; adverse drug reaction; quality of life

Outcome Measures

Primary Outcomes (3)

• 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

• Liver function abnormality

  Change from baseline liver function test

  Change from baseline liver function test on Day 15, and 57

• 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 Outcomes (2)

• Cognitive function assessment

  Change from baseline MCCB on Day 57, and 127

• Clinical symptom assessment

  Change from baseline BPRS on Day 15, and 57

Other Outcomes (1)

• Blood clozapine and its metabolite level

  On Day 15, and 57 after clozapine dosing

Interventions

Clozapine DRUG

Clozapine is administered orally according to individual prescribed dosing regimens.

Also known as: Clozapine treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Patients who are 19 years or older
• Patient who understands the contents of the clinical research and provide their written informed consent forms

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Drug-Related Side Effects and Adverse Reactions

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sang-In Park, Ph. D.

  Kyung Hee University Hospital

  STUDY CHAIR

Central Study Contacts

Euitae Kim, Ph. D.

CONTACT

+82-31-787-7435; euitae.kim@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: June 13, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

KR (1)