Therapeutic Drug Monitoring for Individualized Clozapine Therapy

NCT ID: NCT03523741

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Clozapine

Clozapine is administered orally according to individual prescribed dosing regimens.

Intervention Type DRUG

Other Intervention Names

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Clozapine treatment

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Euitae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-In Park, Ph. D.

Role: STUDY_CHAIR

Kyung Hee University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Euitae Kim, Ph. D.

Role: CONTACT

+82-31-787-7435

Facility Contacts

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Seoyoung Kim, MD

Role: primary

031-787-8219

Other Identifiers

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CLZ_01

Identifier Type: -

Identifier Source: org_study_id

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