The site of the Media Sphera Publishers contains materials intended solely for healthcare professionals.
By closing this message, you confirm that you are a certified medical professional or a student of a medical educational institution.

Filippova N.V.

GBOU VPO "Saratovskiĭ gosudarstvennyĭ meditsinskiĭ universitet im. V.I. Razumovskogo, Saratov

Baryl'nik Iu.B.

GBOU VPO "Saratovskiĭ gosudarstvennyĭ meditsinskiĭ universitet im. V.I. Razumovskogo, Saratov

Shuldyakov A.A.

Razumovsky Saratov State Medical University, Saratov, Russia

Antonova A.A.

Razumovsky Saratov State Medical University, Saratov, Russia

Agomelatine in the treatment of major depressive disorder: assessment of the efficacy and tolerability

Authors:

Filippova N.V., Baryl'nik Iu.B., Shuldyakov A.A., Antonova A.A.

More about the authors

Read: 11399 times


To cite this article:

Filippova NV, Baryl'nik IuB, Shuldyakov AA, Antonova AA. Agomelatine in the treatment of major depressive disorder: assessment of the efficacy and tolerability. S.S. Korsakov Journal of Neurology and Psychiatry. 2019;119(5):154‑161. (In Russ.)
https://doi.org/10.17116/jnevro2019119051154

Recommended articles:
Identification of depression biomarkers: Prospects for use in clinical practice. S.S. Korsakov Journal of Neurology and Psychiatry. 2025;(5):51-55
High-grade astrocytoma with piloid features: case report and systematic review. Burdenko's Journal of Neurosurgery. 2025;(2):83-91
Psychodermatological aspe­cts of psoriasis, current condition of problem. Russian Journal of Clinical Dermatology and Vene­reology. 2025;(4):403-411

References:

  1. EMA Valdoxan (Agomelatine). Summary of product characteristics. 2008.
  2. Kennedy S, Eisfeld B. Agomelatine and its therapeutic potential in the depressed patient. Neuropsych Dis Treat. 2007;3:423-428.
  3. Lerner A, Case J, Takahashi Y, Lee T, Mori W. Isolation of melatonin, the pineal factor that lightens melanocytes. J Am Chem Soc. 1958;80:2587. https://doi.org/10.1021/ja01543a060
  4. Nordlund J, Lerner A. The effects of oral melatonin on skin color and on the release of pituitary hormones. J Clin Endocrinol Metabol. 1977;45:768-774. https://doi.org/10.1210/jcem-45-4-768
  5. Brzezinski A, Vangel M, Wurtman R, Norrie G, Zhdanova I, Ben-Shushan A, Ford I. Effects of exogenous melatonin on sleep: a meta-analysis. Sleep Med Rev. 2005;9:41-50. https://doi.org/10.1016/j.smrv.2004.06.004
  6. Popoli M. Agomelatine innovative pharmacological approach in depression. CNS Drugs. 2009;23(2):27-34. https://doi.org/10.2165/11318640-000000000-00000
  7. Taylor D, Sparshatt A, Varma S, Olofinjana O. Antidepressant efficacy of agomelatine meta-analysis of published and unpublished studies. BMJ. 2014;348:2496. https://doi.org/10.1136/bmj.g1888
  8. Howland R. Publication bias and outcome reporting bias agomelatine as a case example. J Psychosoc Nurs Ment Health Serv. 2011;49:11-14. https://doi.org/10.3928/02793695-20110809-01
  9. Kennedy S, Rizvi S. Agomelatine in the treatment of major depressive disorder potential for clinical effectiveness. CNS Drugs. 2010;24:479-499. https://doi.org/10.2165/11534420-000000000-00000
  10. de Bodinat C, Guardiola-Lemaitre B, Mocaer E, Renard P, Munoz C, Millan M. Agomelatine, the first melatonergic antidepressant: discovery characterization and development. Nat Rev Drug Discov. 2010;9:628-642. https://doi.org/10.1038/nrd3140
  11. Lam R. The importance of early symptom relief in antidepressant treatment focus on agomelatine. J Psychopharmacol. 2010;24:27-30. https://doi.org/10.1177/1359786810372979
  12. Llorca P. The antidepressant agomelatine improves the quality of life of depressed patients implications for remission. J Psycho-pharmacol. 2010;24: 24:21-26. https://doi.org/10.1177/1359786810372978
  13. Hickie I, Rogers N. Novel melatonin-based therapies potential advances in the treatment of major depression. Lancet. 2011;378:621-631. https://doi.org/10.1016/S0140-6736(11)60095-0
  14. San L, Arranz B. Agomelatine a novel mechanism of antidepressant action involving the melatoninergic and the serotonergic system. Eur Psychiatry. 2008;23:396-402. https://doi.org/10.1016/j.eurpsy.2008.04.002
  15. Demyttenaere K. Agomelatine a narrative review. Eur Neuro-psychopharmacol. 2011;21(4):703-709. https://doi.org/10.1016/j.euroneuro.2011.07.004
  16. Koesters M, Guaiana G, Cipriani A, Becker T, Barbui C. Agomelatine efficacy and acceptability revisited systematic review and meta-analysis of published and unpublished randomised trials. Br J Psychiatry. 2013;203:179-187. https://doi.org/10.1192/bjp.bp.112.120196
  17. Cipriani A, Furukawa T, Salanti G, Geddes J, Higgins J, Churchill R, Watanabe N, Nakagawa A, Omori I, McGuire H, Tansella M, Barbui C. Comparative efficacy and acceptability of 12 new-generation antidepressants a multiple-treatments meta-analysis. Lancet. 2009;373:746-758. https://doi.org/10.1016/S0140-6736(09)60046-5
  18. Khoo AL, Zhou HJ, Teng M et al. Network Meta-Analysis and Cost-Effectiveness Generation Antidepressants. CNS Drugs. 2015;29(8):695-712. https://doi.org/10.1007/s40263-015-0267-6
  19. Frolova VI. Overview of the network meta-analysis of the effectiveness of antidepressants new generation. Psikhiatriya i Psikhofarmakoterapiya. 2016;18(6):21-25. (In Russ.)
  20. Guaiana G, Gupta S, Chiodo D, Davies S, Haederle K, Koesters M. Agomelatine versus other antidepressive agents for major depression. Cochrane Database Syst Rev. 2013;12:CD008851. https://doi.org/10.1002/14651858.CD008851
  21. Gahr M, Freudenmann R, Connemann B, Hiemke C, Schönfeldt-Lecuona C. Agomelatine and hepatotoxicity implications of cumulated data derived from spontaneous reports of adverse drug reactions. Pharmacopsychiatry. 2013;56:214-220. https://doi.org/10.1055/s-0033-1353156
  22. Montastruc F, Scotto S, Vaz I, Guerra L, Escudero A, Sáinz M, Falomir T, Bagheri H, Herdeiro m, Venegoni M, Montastruc J, Carvajal A. Hepatotoxicity Related to Agomelatine and Other New Antidepressants A Case/Noncase Approach With Information From the Portuguese, French, Spanish, and Italian Pharmacovigilance Systems. J Clin Psychopharmacol. 2014;34:327-330. https://doi.org/10.1097/JCP.0000000000000094
  23. Gahr M. Agomelatine in the Treatment of Major Depressive Disorder: An Assessment of Benefits and Risks. Curr Neuropharmacol. 2014;12(5):287-398. https://doi.org/10.2174/1570159X12999140619122914
  24. Millan M, Gobert A, Lejeune F, Dekeyne A, Newman-Tancredi A, Pasteau V, Rivet J, Cussac D. The novel melatonin agonist agomelatine (S20098) is an antagonist at 5-hydroxytryptamine2C receptors, blockade of which enhances the activity of frontocortical dopaminergic and adrenergic pathways. J Pharmacol Exp Ther. 2003;306:954-964. https://doi.org/10.1124/jpet.103.051797
  25. Kennedy S, Rivzi S, Fulton K, Rasmussen J. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J Clin Psychopharmacol. 2008;28:329-333. https://doi.org/10.1097/JCP.0b013e318172b48c
  26. Lemoine P, Guilleminault C, Alvarez E. Improvement in subjective sleep in major depressive disorder with a novel antidepressant, agomelatine randomized, double-blind comparison with venlafaxine. J Clin Psychiatry. 2007;68:1723-1732. https://doi.org/10.4088/jcp.v68n1112
  27. Kasper S, Hajak G, Wulff K, Hoogendijk W, Montejo A, Smeraldi E, Rybakowski J, Quera-Salva M, Wirz-Justice A, Picarel-Blanchot F, Baylé F. Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder a randomized, double-blind comparison with sertraline. J Clin Psychiatry. 2010;71:109-120. https://doi.org/10.4088/JCP.09m05347blu
  28. Quera-Salva M, Hajak G, Philip P, Montplaisir J, Keufer-Le Gall S, Laredo J, Guilleminault C. Comparison of agomelatine and escitalopram on nighttime sleep and daytime condition and efficacy in major depressive disorder patients. Int Clin Psycho-pharmacol. 2011;26:252-262. https://doi.org/10.1097/YIC.0b013e328349b117
  29. Heun R, Ahokas A, Boyer P, Giménez-Montesinos N, Pontes-Soares F, Olivier V, Group AS. The efficacy of agomelatine in elderly patients with recurrent major depressive disorder a placebo-controlled study. J Clin Psychiatry. 2013;74:587-594. https://doi.org/10.4088/JCP.12m08250
  30. Martinotti G, Sepede G, Gambi F, Di Iorio G, De Berardis D, Di Nicola M, Onofrj M, Janiri L, Di Giannantonio M. Agomelatine versus venlafaxine XR in the treatment of anhedonia in major depressive disorder: a pilot study. J Clin Psycho-pharmacol. 2012;32:487-491. https://doi.org/10.1097/JCP.0b013e31825d6c25
  31. EMEA. Questions and answers on recommendation for refusal of marketing authorisation for Valdoxan/Thymanax. 2006.
  32. EMEA.CHMP assessment report for valdoxan. 2008. Accessed May 5th. 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000915/WC500046226.pdf
  33. EMA Post authorisation opinion regarding Agomelatine. Journal name. 2013.
  34. Howland R. A benefit-risk assessment of agomelatine in the treatment of major depression. Drug Saf. 2011;34:709-731. https://doi.org/10.2165/11593960-000000000-00000
  35. Fornaro M, Prestia D, Colicchio S, Perugi G. A systematic, updated review on the antidepressant agomelatine focusing on its melatoninergic modulation. Curr Neuropsychopharmacol. 2010;8:287-304. https://doi.org/10.2174/157015910792246227
  36. Montgomery S, Möller H. Is the significant superiority of escitalopram compared with other antidepressants clinically relevantκ. Int Clin Psychopharmacol. 2009;24:111-118. https://doi.org/10.1097/YIC.0b013e32832a8eb2
  37. Melander H, Salmonson T, Abadie E, van Zwieten-Boot B. A regulatory Apologia — a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants. Eur Neuropsychopharmacol. 2008;18:623-627. https://doi.org/10.1016/j.euroneuro.2008.06.003
  38. Turner E, Matthews A, Linardatos E, Tell R, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358:252-260. https://doi.org/10.1056/NEJMsa065779
  39. Cipriani A, Furukawa TA, Salanti G, Chaimani BA, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JPT, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JPA, Geddes JR. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. The Lancet. 2018;391:1357-1366. https://doi.org/10.1016/S0140-6736(17)32802-7
  40. Goodwin G, Boyer P, Emsley R, Rouillon F, de Bodinat C. Is it time to shift to better characterization of patients in trials assessing novel antidepressants? An example of two relapse prevention studies with agomelatine. Int Clin Psychopharmacol. 2013;1:20-28. https://doi.org/10.1097/YIC.0b013e32835b0814
  41. Corruble E, de Bodinat C, Belaïdi C, Goodwin G. Agomelatine study group. Efficacy of agomelatine and escitalopram on depression subjective sleep and emotional experiences in patients with major depressive disorder a 24-wk randomized, controlled, double-blind trial. Int J Neuropsychopharmacol. 2013;16:2219-2234. https://doi.org/10.1017/S1461145713000679
  42. Froböse T, Slawik H, Schreiner R, Veselý Z, Wiegand M, Bäuml J, Förstl H. Agomelatine improves sleep in a patient with fatal familial insomnia. Pharmacopsychiatry. 2012;45:34-36. https://doi.org/10.1055/s-0031-1287778
  43. Baryl’nik YuB, Filippova NV, Trayber LV. Modern approaches to the synchronization of circadian rhythms during depression. Zhurnal Nevrologii i Psikhiatrii im. S.S. Korsakova. 2014;11:124-128. (In Russ.)
  44. Medvedev VE, Retyunskiy KYu, Ovchinnikov AA, Baryl’nik YuB, Shmilovich AA, Antokhin EYu, Usov GM, Cheremin RA, Poletskiy VM, Onegin AV, Kireyeva IP, Frolova VI, Filippova NV, Antonova AA, Deyeva MA, Onegina DA. Differences in the assessment of the severity of depression by doctors and patients in the process of combination therapy with agomelatine (multicenter study «Emotion»). Zhurnal Nevrologii i Psikhiatrii im. C.C. Korsakova. 2016;116(11):26-34. (In Russ.) https://doi.org/10.17116/jnevro201611611126-34
  45. Medvedev VE, Retyunskii KYu, Ovchinnikov AA, Baryl’nik YuB, Shmilovich AA, Antokhin EYu, Usov GM, Cheremin RA, Poletskii VM, Onegin AV, Kireeva IP, Frolova VI, Filippova NV, Antonova AA, Deeva MA, Onegina DA. Differences in assessment of the severity of depression by doctors and patients during combined therapy with agomelatine (the emotion multicenter trial). Neuroscience and Behavioral Physiology. 2018;48(3):367-376. https://doi.org/10.1007/s11055-018-0572-x

Email Confirmation

An email was sent to test@gmail.com with a confirmation link. Follow the link from the letter to complete the registration on the site.

Email Confirmation

We use cооkies to improve the performance of the site. By staying on our site, you agree to the terms of use of cооkies. To view our Privacy and Cookie Policy, please. click here.