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AzTrials

Polymorphism, GeneticNCT06120543

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

An observational study of Polymorphism, Genetic and Depression, run by Affiliated Hospital of Nantong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years
How many people
50 participants
Where
No sites listed yet
Study dates
31 Oct 2023to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult depression patients

Who may be able to join

  • Clinical diagnosis of depression; Sleep disorder.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Qin Wang contact

+8618921600968

wangqin@ntu.edu.cn

About this study

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

  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.
Keywords
gene polymorphism, plasma concentration, agomelatine, adult depression
Medical subject headings
Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma concentration of Agomelatine

    Plasma concentration of Agomelatine

    Measured: 3 hours after the patients take agomelatine

  2. CYP1A2, ABCB1, and CYP2C9 genotypes

    CYP1A2, ABCB1, and CYP2C9 gene polymorphism

    Measured: 3 hours after the patients take agomelatine

  3. Plasma concentration of Agomelatine metabolites

    Plasma concentration of Agomelatine metabolites

    Measured: 3 hours after the patients take agomelatine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start31 Oct 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120543
Sponsor's protocol ID
wangqin01
Status last verified
Aug 2023
First submitted
1 Nov 2023
Last updated
7 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Polymorphism, Genetic and Depression, run by Affiliated Hospital of Nantong University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qin Wang (+8618921600968, wangqin@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentration of Agomelatine (time frame: 3 hours after the patients take agomelatine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120543, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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