Therapeutic Drug Monitoring for Individualized Clozapine Therapy
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|ClinicalTrials.gov Identifier: NCT03523741|
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment|
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- Drug: Clozapine
Clozapine is administered orally according to individual prescribed dosing regimens.Other Name: Clozapine treatment
- 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
- Liver function abnormality [ Time Frame: Change from baseline liver function test on Day 15, and 57 ]Change from baseline liver function test
- 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.
- Cognitive function assessment [ Time Frame: Change from baseline MCCB on Day 57, and 127 ]MCCB (MATRICS Consensus Cognitive Battery).
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523741
|Contact: Euitae Kim, Ph. D.||+email@example.com|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam, Korea, Republic of, 13620|
|Contact: Seoyoung Kim, MD 031-787-8219 firstname.lastname@example.org|
|Study Chair:||Sang-In Park, Ph. D.||Kyung Hee University Hospital|