A Research in Pharmacogenomics and Accurate Medication of Risperidone

Schizophrenia Clinical Trial

Official title:

A Research in Pharmacogenomics and Accurate Medication of Risperidone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302364
• Other study ID #: 2016[1240]
• Status: Recruiting
• Start date: October 22, 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Peking University First Hospital
• Contact: Qian Xiang, Ph.D
• Phone: +86 010 66110802
• Email: xiangqz[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Schizophrenia

Intervention

Drug:
• Risperidone
patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genotype	The genotypes of subjects are detected.	Pre-dose of risperidone
Secondary	Prolactin concentration in plasma	Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin.	Hour 0, Weeks 6-8
Secondary	risperidone and 9-OH-risperidone concentration in plasma	Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation.	day 1,day 2
Secondary	Negative and positive scale	PANSS scole of patients	day-1,day28±2,day56±2