A Research in Pharmacogenomics and Accurate Medication of Risperidone

NCT03302364 | Unknown

• 1 other identifier: 2016[1240]
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Mental Illness

Outcome Measures

Primary Outcomes (1)

• genotype

  The genotypes of subjects are detected.

  Pre-dose of risperidone

Secondary Outcomes (3)

• Prolactin concentration in plasma

  Hour 0, Weeks 6-8

• risperidone and 9-OH-risperidone concentration in plasma

  day 1,day 2

• Negative and positive scale

  day-1,day28±2，day56±2

Study Arms (1)

risperidone patients

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

Drug: Risperidone

Interventions

Risperidone DRUG

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

Also known as: Risperidal

risperidone patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Schizophrenic patients who are going to be treated with risperidone.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cui Yimin: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be drawn and collected, serum sample will also be obtained by centrifugation of whole blood at 4 ℃. The collected samples will be further detected and the concentration data will be used for PG-PK, PG-PD and PG-ADR analyses.

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yimin Cui, Ph.D & M.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Xiang, Ph.D

CONTACT

+86 010 66110802; xiangqz@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Pharmacy,M.D.& Ph.D.

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 5, 2017
• Study Start: October 22, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

CN (1)