Mental Illness, Schizophrenia
Conditions
Brief 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.
Interventions
DRUGRisperidone
patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment
Sponsors
Cui Yimin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| genotype | Pre-dose of risperidone | The genotypes of subjects are detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| risperidone and 9-OH-risperidone concentration in plasma | day 1,day 2 | Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation. |
| Negative and positive scale | day-1,day28±2，day56±2 | PANSS scole of patients |
| Prolactin concentration in plasma | Hour 0, Weeks 6-8 | Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin. |
Countries
China
Contacts
Primary ContactQian Xiang, Ph.D
Outcome results
None listed