A Research in Pharmacogenomics and Accurate Medication of Risperidone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Research in Pharmacogenomics and Accurate Medication of Risperidone

Conditions
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Schizophrenia, Mental Illness

Intervention / Treatment
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* Drug: Risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients that meet with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychiatric Interview (MINI); patients who have never received risperidone treatment or who need re-administration of risperidone after previous treatment with risperidone; Subjects and / or their guardians who agree to sign the informed consent. Exclusion Criteria: patients who use CYP2D6 or CYP3A4 inducers or inhibitors as treatment drugs; patients with hepatic insufficiency; patients with renal insufficiency; patients who use other drugs that interact with risperidone; certain patients that the researchers consider to be unsuitable for the clinical trail.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| risperidone patients<br>patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI) | Drug: Risperidone<br>* patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment<br>* Other names: Risperidal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype | The genotypes of subjects are detected. | Pre-dose of risperidone | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |