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Not yet recruitingNCT06120543Updated Nov 7, 2023

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

An observational study in Polymorphism, Genetic, Depression and CYP1A2 Polymorphism, sponsored by Affiliated Hospital of Nantong University. Not yet recruiting. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Affiliated Hospital of Nantong University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
50
Ages
18 Years to 69 Years
Sex
All
01

Study summary

  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.
Read the detailed description
  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

  1. The blood drug concentration monitoring method should have a certain degree of precision and accuracy, and meet the relevant requirements of the Chinese Pharmacopoeia; The gene detection method is required to be fast and simple, and the internal and external quality control should be carried out;
  2. The medical record data should be collected completely, the privacy of patients should be respected, and the blood sample storage should meet the relevant conditions through the review of the hospital ethics committee;
  3. The refined medication guidance scheme of agomelatine can be formed based on the data of therapeutic drug monitoring, gene detection and clinical research.
02

Conditions studied

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

Keywords

  • gene polymorphism
  • plasma concentration
  • agomelatine
  • adult depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 50 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult depression patients

Inclusion criteria

Clinical diagnosis of depression; Sleep disorder.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Plasma concentration of Agomelatine

    Plasma concentration of Agomelatine

    Time frame: 3 hours after the patients take agomelatine

  2. CYP1A2, ABCB1, and CYP2C9 genotypes

    CYP1A2, ABCB1, and CYP2C9 gene polymorphism

    Time frame: 3 hours after the patients take agomelatine

  3. Plasma concentration of Agomelatine metabolites

    Plasma concentration of Agomelatine metabolites

    Time frame: 3 hours after the patients take agomelatine

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 34592623 ↗
  • 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. Erratum In: Lancet Psychiatry. 2022 Mar;9(3):e10. doi: 10.1016/S2215-0366(22)00037-2. PubMed 34919834 ↗
  • 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. PubMed 32568567 ↗
  • 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. PubMed 18583104 ↗
  • 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. PubMed 30789308 ↗
  • 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. PubMed 24724693 ↗
  • 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. PubMed 26409931 ↗
  • 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. PubMed 30761579 ↗
  • 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. PubMed 37832460 ↗
  • 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. PubMed 30411255 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06120543
Lead sponsor
Affiliated Hospital of Nantong University
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Oct 31, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Nov 7, 2023

Study contacts

Qin Wang
Contact
wangqin@ntu.edu.cn
+8618921600968
Qin Wang
study director · Affiliated Hospital of Nantong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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