NCT03302364

A Research in Pharmacogenomics and Accurate Medication of Risperidone

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Cui Yimin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Schizophrenia
• Mental Illness

Interventions

Type	Name	Description
DRUG	Risperidone	patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment

Timeline

• Start date: 2017-10-22
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-10-05
• Last updated: 2019-08-29

Locations

1 site across 1 country: China