CYP1A2, ABCB1, CYP2C9 and Plasma Concentration of Agomelatine in Adult Patients With Depression

NCT06120543 | Unknown

• 1 other identifier: wangqin01
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Polymorphism, Genetic; Depression; CYP1A2 Polymorphism; CYP2C9 Polymorphism; Polymerase Chain Reaction; Plasma Concentration

Keywords

gene polymorphism; plasma concentration; agomelatine; adult depression

Outcome Measures

Primary Outcomes (3)

• Plasma concentration of Agomelatine

  Plasma concentration of Agomelatine

  3 hours after the patients take agomelatine

• CYP1A2, ABCB1, and CYP2C9 genotypes

  CYP1A2, ABCB1, and CYP2C9 gene polymorphism

  3 hours after the patients take agomelatine

• Plasma concentration of Agomelatine metabolites

  Plasma concentration of Agomelatine metabolites

  3 hours after the patients take agomelatine

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult depression patients

You may qualify if:

• Clinical diagnosis of depression; Sleep disorder.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Related Publications (10)

• Maddukuri RK, Hema C, Sri Tejaswi K, Venkata Mounika M, Vegesana BP. Antidepressant efficacy of Agomelatine: Meta-analysis of placebo controlled and active comparator studies. Asian J Psychiatr. 2021 Nov;65:102866. doi: 10.1016/j.ajp.2021.102866. Epub 2021 Sep 20.

  PMID: 34592623 BACKGROUND

• Arango C, Buitelaar JK, Fegert JM, Olivier V, Penelaud PF, Marx U, Chimits D, Falissard B; study investigators. Safety and efficacy of agomelatine in children and adolescents with major depressive disorder receiving psychosocial counselling: a double-blind, randomised, controlled, phase 3 trial in nine countries. Lancet Psychiatry. 2022 Feb;9(2):113-124. doi: 10.1016/S2215-0366(21)00390-4. Epub 2021 Dec 14.

  PMID: 34919834 BACKGROUND

• Konstantakopoulos G, Dimitrakopoulos S, Michalopoulou PG. The preclinical discovery and development of agomelatine for the treatment of depression. Expert Opin Drug Discov. 2020 Oct;15(10):1121-1132. doi: 10.1080/17460441.2020.1781087. Epub 2020 Jun 22.

  PMID: 32568567 BACKGROUND

• San L, Arranz B. Agomelatine: a novel mechanism of antidepressant action involving the melatonergic and the serotonergic system. Eur Psychiatry. 2008 Sep;23(6):396-402. doi: 10.1016/j.eurpsy.2008.04.002. Epub 2008 Jun 25.

  PMID: 18583104 BACKGROUND

• Saiz-Rodriguez M, Ochoa D, Belmonte C, Roman M, Vieira de Lara D, Zubiaur P, Koller D, Mejia G, Abad-Santos F. Polymorphisms in CYP1A2, CYP2C9 and ABCB1 affect agomelatine pharmacokinetics. J Psychopharmacol. 2019 Apr;33(4):522-531. doi: 10.1177/0269881119827959. Epub 2019 Feb 21.

  PMID: 30789308 RESULT

• Guardiola-Lemaitre B, De Bodinat C, Delagrange P, Millan MJ, Munoz C, Mocaer E. Agomelatine: mechanism of action and pharmacological profile in relation to antidepressant properties. Br J Pharmacol. 2014 Aug;171(15):3604-19. doi: 10.1111/bph.12720.

  PMID: 24724693 RESULT

• Li M, Tang F, Xie F, Lv Y, Yu P, Liu Z, Cheng Z. Development and validation a LC-MS/MS method for the simultaneous determination of agomelatine and its metabolites, 7-desmethyl-agomelatine and 3-hydroxy-agomelatine in human plasma: Application to a bioequivalence study. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 15;1003:60-6. doi: 10.1016/j.jchromb.2015.09.018. Epub 2015 Sep 18.

  PMID: 26409931 RESULT

• Xie F, Vermeulen A, Colin P, Cheng Z. A semiphysiological population pharmacokinetic model of agomelatine and its metabolites in Chinese healthy volunteers. Br J Clin Pharmacol. 2019 May;85(5):1003-1014. doi: 10.1111/bcp.13902. Epub 2019 Mar 21.

  PMID: 30761579 RESULT

• El-Deen AK, Magdy G, Shimizu K. A reverse micelle-mediated dispersive liquid-liquid microextraction coupled to high-performance liquid chromatography for the simultaneous determination of agomelatine and venlafaxine in pharmaceuticals and human plasma. J Chromatogr A. 2023 Nov 8;1710:464441. doi: 10.1016/j.chroma.2023.464441. Epub 2023 Oct 10.

  PMID: 37832460 RESULT

• Zhang H, Pu C, Wang Q, Tan X, Gou J, He H, Zhang Y, Yin T, Wang Y, Tang X. Physicochemical Characterization and Pharmacokinetics of Agomelatine-Loaded PLGA Microspheres for Intramuscular Injection. Pharm Res. 2018 Nov 8;36(1):9. doi: 10.1007/s11095-018-2538-7.

  PMID: 30411255 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

2ml of venous blood collected in ethylenediamine tetraacetic acid anticoagulant tubes

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Qin Wang

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Central Study Contacts

Qin Wang

CONTACT

+8618921600968; wangqin@ntu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: October 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share