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Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6 genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting the type and dose of medication to treat Schizophrenia. In this study, we will verify the correlation between the polymorphisms of genes related with risperidone drug metabolites, drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in Chinese population, providing basis for clinical rational use of risperidone.
Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration. Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum prolactin levels) will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| risperidone patients | patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| genotype | The genotypes of subjects are detected. | Pre-dose of risperidone |
| Measure | Description | Time Frame |
|---|---|---|
| Prolactin concentration in plasma | Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin. | Hour 0, Weeks 6-8 |
| risperidone and 9-OH-risperidone concentration in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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Schizophrenic patients who are going to be treated with risperidone.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Xiang, Ph.D | Contact | +86 010 66110802 | xiangqz@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yimin Cui, Ph.D & M.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Whole blood samples will be drawn and collected, serum sample will also be obtained by centrifugation of whole blood at 4 ℃. The collected samples will be further detected and the concentration data will be used for PG-PK, PG-PD and PG-ADR analyses.
|
Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation.
| day 1,day 2 |
| Negative and positive scale | PANSS scole of patients | day-1,day28±2,day56±2 |