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临床试验/NCT06120543
NCT06120543尚未招募不适用

Correlation Between CYP1A2, ABCB1, CYP2C9 Gene Polymorphisms and Plasma Concentration of Agomelatine and Its Metabolites in Adult Patients With Depression

Affiliated Hospital of Nantong University0 个研究点目标入组 50 人开始时间: 2023年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Plasma concentration of Agomelatine metabolites

研究概览

简要总结

  1. The plasma concentrations of agomelatine and its two metabolites are simultaneously determined by High performance liquid chromatography-tandem mass spectrometry;
  2. The gene polymorphisms of CYP1A2, ABCB1 and CYP2C9 are detected by fluorescence in situ hybridization or fluorescence polymerase chain reaction;
  3. The correlation of CYP1A2, ABCB1, CYP2C9 gene polymorphisms with the blood concentration of agomelatine and its two metabolites is investigated by pharmacokinetic study;
  4. According to the correlation between the above genotypes and blood drug concentration, a lean medication guidance scheme for agomelatine will be formed.

详细描述

  1. research purpose and significance Through blood concentration monitoring, pharmacokinetics and gene detection technology, combined with clinical prospective research, the lean medication of agomelatine will be achieved. Objective to establish a method for analyzing the blood concentration of agomelatine and its two metabolites, which can be applied to routine detection in hospital. Objective to search for the genes related to the metabolism of agomelatine in vivo, and to detect the polymorphisms of related genes quickly and easily by fluorescence in situ hybridization or micro sequencing technology. Objective to explore the correlation between gene polymorphism and blood concentration of agomelatine and its two metabolites, and to make reasonable pharmaceutical recommendations for clinical lean drug use.
  2. research content and design The plasma concentrations of agomelatine and its two metabolites are simultaneously detected by High performance liquid chromatography-tandem mass spectrometry; The gene polymorphisms of CYP1A2, ABCB1 and CYP2C9 are detected by fluorescence in situ hybridization or microsequencing; Objective to explore the correlation between CYP1A2, ABCB1, CYP2C9 gene polymorphisms and the blood concentration of agomelatine and its two metabolites by pharmacokinetic study.
  3. research object

50 adult depression patients taking agomelatine

4 research steps

  1. The plasma concentrations of agomelatine and its two metabolites are simultaneously detected by High performance liquid chromatography-tandem mass spectrometry;
  2. The gene polymorphisms of CYP1A2, ABCB1 and CYP2C9 are detected by fluorescence in situ hybridization or fluorescence polymerase chain reaction;
  3. The correlation of CYP1A2, ABCB1, CYP2C9 gene polymorphisms with the blood concentration of agomelatine and its two metabolites is investigated by pharmacokinetic study;
  4. According to the correlation between the above genotypes and blood drug concentration, a lean medication guidance scheme for agomelatine will be formed.

5 evaluation index

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of depression; Sleep disorder.

排除标准

  • Mental disorder; Intelligence disorder; Dementia; Aphasia; Dysarthria; Consciousness disorder; Severe heart, kidney or liver dysfunction; Pregnant and lactating women; Malignant tumor.

结局指标

主要结局

Plasma concentration of Agomelatine metabolites

时间窗: 3 hours after the patients take agomelatine

Plasma concentration of Agomelatine metabolites

Plasma concentration of Agomelatine

时间窗: 3 hours after the patients take agomelatine

Plasma concentration of Agomelatine

CYP1A2, ABCB1, and CYP2C9 genotypes

时间窗: 3 hours after the patients take agomelatine

CYP1A2, ABCB1, and CYP2C9 gene polymorphism

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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