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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug | Clozapine is administered orally according to individual prescribed dosing regimens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Change from baseline sleeping tendency assessment on Day 15, and 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function assessment | MCCB (MATRICS Consensus Cognitive Battery). | Change from baseline MCCB on Day 57, and 127 |
| Clinical symptom assessment | Brief Psychiatric Rating Scale (BPRS).
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Euitae Kim, Ph. D. | Contact | +82-31-787-7435 | euitae.kim@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang-In Park, Ph. D. | Kyung Hee University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from baseline BPRS on Day 15, and 57 |