A Research in Pharmacogenomics and Accurate Medication of Risperidone

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Mental Illness
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Qian Xiang, Ph.D; Phone Number: 01066110802; Email: xiangqz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Schizophrenic patients who are going to be treated with risperidone.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cui Yimin
• Investigators: Principal Investigator: Yimin Cui, Ph.D & M.D, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: 2016[1240]

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No