A Research in Pharmacogenomics and Accurate Medication of Risperidone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-22

Study Completion Date

2020-06-30

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.

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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.

Conditions

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Schizophrenia Mental Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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risperidone patients

patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI)

Risperidone

Intervention Type DRUG

patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment

Interventions

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Risperidone

patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment

Intervention Type DRUG

Other Intervention Names

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Risperidal

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No