Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Drug Monitoring for Individualized Clozapine Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523741
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Euitae Kim, Seoul National University Bundang 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

Condition or disease Intervention/treatment
Schizophrenia Drug: Clozapine

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinical Trial to Investigate the Factors Affecting Adverse Drug Reactions and Clinical Efficacy of Clozapine in Korean
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine


Intervention Details:
  • Drug: Clozapine
    Clozapine is administered orally according to individual prescribed dosing regimens.
    Other Name: Clozapine treatment


Primary Outcome Measures :
  1. Glucose and lipid metabolism abnormality [ Time Frame: Change from baseline glucose and lipid profiles on Day 15, and 57 ]
    Change from baseline glucose and lipid profiles after clozapine administration

  2. Liver function abnormality [ Time Frame: Change from baseline liver function test on Day 15, and 57 ]
    Change from baseline liver function test

  3. Sleeping tendency assessment [ Time Frame: 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.


Secondary Outcome Measures :
  1. Cognitive function assessment [ Time Frame: Change from baseline MCCB on Day 57, and 127 ]
    MCCB (MATRICS Consensus Cognitive Battery).

  2. Clinical symptom assessment [ Time Frame: 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.


Other Outcome Measures:
  1. Blood clozapine and its metabolite level [ Time Frame: On Day 15, and 57 after clozapine dosing ]
    Relationship between occurrence of clozapine adverse drug reactions and clozapine blood concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523741


Contacts
Layout table for location contacts
Contact: Euitae Kim, Ph. D. +82-31-787-7435 euitae.kim@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13620
Contact: Seoyoung Kim, MD    031-787-8219    zentiana0@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Sang-In Park, Ph. D. Kyung Hee University Hospital
Layout table for additonal information
Responsible Party: Euitae Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03523741    
Other Study ID Numbers: CLZ_01
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Euitae Kim, Seoul National University Bundang Hospital:
genetic polymorphism
pharmacodynamic variability
personalized pharmacotherapy
adverse drug reaction
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents