Comparative efficacy of agomelatine versus sertraline in major depressive disorder in Himalayan region of India

Authors

  • Anil Kumar Mehta Department of Pharmacology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India
  • D. D. Gupta Department of Pharmacology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India
  • Ramesh Kumar Department of Psychiatry, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India
  • Atal Sood Department of Pharmacology, Dr. Rajendra Prasad Government Medical College, Kangra, Tanda, Himachal Pradesh, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20174359

Keywords:

Agomelatine, Circadian rhythm, Depression, Sertraline

Abstract

Background: Depression, a major common affective disorder which carries excess mortality through suicide. Among various drug classes available SSRI’s are usually a choice, but many patients show inadequate response, residual symptoms or discontinue medication due to intolerable side effects. Disturbances of circadian rhythm function are an etiopathogenic hallmark of depression. The degree of circadian misalignment correlates with the severity of depression and circadian abnormalities may partially be a consequence of alterations in behavior and sleep patterns that accompany depression. Agomelatine an agonist acts on MT1 and MT2 receptors and antagonist of 5HT2c receptors contributes to its resynchronization of circadian rhythms, enhancement of dopaminergic and adrenergic input to the frontal cortex, induction of hippocampal neurogenesis, and ultimately, to its antidepressant effect.

Methods: The study was randomized, prospective, comparative and interventional regarding the efficacy of therapy. Hundred consenting patients of MDD attending psychiatry OPD were screened for possible enrollment into group A(Agomelatine) and group B(Sertraline). Patients were assessed by semi-structured case recording form, DSM-IV- TR Criteria for major depressive episode, Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions for severity (CGI-S) at baseline and CGI for improvement (CGI-I), every two weeks interval and final assessment at 8 weeks.

Results: Socio-demographic parameters like age and sex distribution, marital status, locality, family type, educational status, occupation and socio-economic class were comparable between two groups. Similarly baseline HAM-D and CGI-S values between the two groups were statistically non-significant. HAM-D, CGI-S and CGI-I values at eight weeks among the two groups were also statistically non-significant but in all three sertraline had decreased the values to a greater extent and showed a trend towards improvement.

Conclusions: Both groups had shown significant decrease in scores of all scales i.e. HAM-D, CGI-S, and CGI-I at the end of 8th week as compared to baseline scores, indicating that the uses of agomelatine and sertraline have resulted in significant improvement in symptoms of patients of MDD and reinforcing there efficacy in treatment of MDD. No statistical difference was observed between two groups. 

References

The global burden of disease. 2004 update. Geneva: World Health Organization; 2008 [homepage on the Internet]. c2011. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report2004.

Lund C, Breen A, Flisher AJ, Kakuma R, Corrigall J, Joska JA, et al. Poverty and common mental disorders in low and middle-income countries: A systematic review. Soc Sci Med. 2010;71:517‑28.

Math SB, Chandrashekar CR, Bhugra D. Psychiatric epidemiology in India. Indian J Med Res. 2007;126:183.

Simon GE, Von Korff M. Suicide mortality among patients treated for depression in an insured population. Am J Epidemiol. 1998;147:155‑60.

Kirmayer LJ, Groleau D. Affective disorders in cultural context. Psychiatr Clin North Am. 2001;24:465‑78.

Hirschfeld RMA, Weissman MM. Risk factors for major depression and bipolar disorder. In: Davis KL, Charney D, Coyle JT editors. Neuropsychopharmacology: the fifth generation of progress. Philadelphia (PA): Lippincott Williams & Wilkins. 2002:1017-1025.

Health NCC for M. Depression: The NICE guideline on the treatment and management of depression in adults. Great Britain: The British Psychological Society and The Royal College of Psychiatrists; 2010.

Johnson JA. Pharmacogenetics: Potential for individualized drug therapy through genetics. Trends Genet. 2003;19:660‑6.

Outhoff K. Agomelatine: a review for general practitioners. S Afr Fam Pract. 2012;54(3):181-7.

Lader M. Limitation of current medical treatments for depression: disturbed circadian rhythms as a possible therapeutic target. Eur Neuropsychopharmacol. 2007;17:743-55.

Takahashi JS, Hong HK, Ko CH, McDearmon EL. The genetics of mammalian circadian order and disorder: Implications for physiology and disease. Nat Rev Genet. 2008;9:764-75.

Racagni G, Riva MA, Popoli M. The interaction between the internal clock and antidepressant efficacy. Int Clin Psychopharmacol. 2007;22(2):S9-14.

Kennaway DJ. Clock genes at the heart of depression. J Psychopharmacol. 2010;24(8):5-14.

Dibner C, Schibler U, Albrecht U. The mammalian circadian timing system: Organisation and coordination of central and peripheral clocks. Annu Rev Physiol. 2010;72:517-49.

Hajak G, Landgrebe M. Time and depression. When the internal clock does not work. Medicographica. 2010;32:146-51.

De Bodinat C, Guardiola-Lemaitre B, Mocaër E, Renard P, Muňoz C, Millan MJ. Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nat Rev Drug Discov. 2010;9(8):628-42.

Etain B, Milhiet V, Bellvier F, Leboyer M. Genetics of circadian rhythms and mood spectrum disorders. Eur Neuropsychopharmacol. 2011;21:676-82.

Hickie IB, Rogers NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet. 2011;378(9791):621-31.

San L, Arranz B. Agomelatine: a novel mechanism of antidepressant action involving the melatonergic and the serotonergic system. Eur Psychiatry. 2008;23(6):396-02.

Saygın MZ, Sungur MZ, Sabol EU, Cetinkaya P. Nefazodone versus sertraline in the treatment of posttraumatic stress disorder. Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology. 2002;12:1-5.

Sanchez C, Reines EH, Montgomery SA. A comparative review of escitalopram, paroxetine, and sertraline: are they all alike?. International Clinical Psychopharmacology. 2014;29(4):185-96.

Akisal HS. Mood disorders: Clinical features. DSM-IV-TR criteria for major depressive episode Diagnostic and statistical manual of mental disorders. 4th ed. Text rev. Washington, DC: American Psychiatric Association. 2000;1611-52.

Hamilton M. Hamilton Psychiatric Rating Scale for Depression. ECDEU Assessment Manual for Psychopharmacology, Guy W, ed, Rockville, MD: U.S. Department of Health, Education, and Welfare. 1976;179-192.

Guy W. Clinical Global Impression (CGI) ECDEU Assessment Manual for Psychopharmacology. US Department of Health Education and Welfare publication (ADM). 1976:76-338.

Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder. Potential for clinical effectiveness. CNS Drugs. 2010;24(6):479-99.

Kennedy SH, Eisfeld BS, Meyer JH, Bagby RM. Antidepressants in clinical practice: limitations of assessment methods and drug response. Hum Psychopharmacol. 2001;16(1):105-14.

Zlotos DP. Recent advances in melatonin receptor ligands. Arch Pharm Chem Life Sci. 2005;338:229-47.

Landolt HP, Wehrle R. Antagonism of serotonergic 5-HT2A/2C receptors: mutual improvement of sleep, cognition, and mood? Eur J Neurosci. 2009;29:1795-809.

American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder. 3rd Ed. Arlington, VA:APA; 2010.

Wilson S, Argyropoulos S. Antidepressants and sleep: a qualitative review of the literature. Drugs. 2005;65(7):927-47.

Hale A, Corral RM, Mencacci C, Ruiz JS, Severo CA, Gentil V. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. International clinical psychopharmacology. 2010 Nov 1;25(6):305-14.

Loo H, Hale A, D’Haenen H. Determination of the dose of agomelatine, a melatonergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. Int Clin Psychopharmacol. 2002;17(5):239-47.

Olie JP, Kasper S. Efficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorder. Int J Neuropsychopharmacol. 2007;10:661-73.

Ministry of Home Affairs, Government of India: Census 2011. Available at: censusindia.gov.in. (Accessed 2015, Oct 15).

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;68:1723-32.

Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. The lancet. 2009 Mar 6;373(9665):746-58.

Thase ME, Ninan PT, Musgnung JJ, Trivedi MH. Remission with venlafaxine extended release or selective serotonin reuptake inhibitors in depressed patients: a randomized, open-label study. Prim Care Companion CNS Disord. 2011;13(1):965-79.

Kumar BPR, Dudala SR, Rao AR. Kuppuswamy’s Socioeconomic Status Scale-A revision of economic parameter for 2012. Int J Research and Development of Health. 2013;1(1):2-4.

Stahl SM, Fava M, Trivedi MH, Caputo A, Shah A, Post A. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry. 2010;71(5):616-26.

Novartis. Efficacy, safety and tolerability of agomelatine in the treatment of major depressive disorder [Clinical Trials. gov identifier NCT00411242]. US National Institutes of Health, Clinical Trials. gov [online]. Available at: http://www.clinicaltrials.gov [Accessed 2015 Oct 13]

Novartis. A placebo- and paroxetine-controlled study of the efficacy, safety and tolerability of agomelatine (25 or 50 mg) in the treatment of major depressive disorder (MDD) [ClinicalTrials.gov identifier NCT00463242]. US National Institutes of Health, Clinical Trials.gov [online]. Available at: http://www.clinicaltrials.gov [Accessed 2015 Oct 13]

Pjrek E, Winkler D, Konstantinidis A. Agomelatine in the treatment of seasonal affective disorder. Psychopharmacology. 2007;190:575-9.

Corruble E, Belaidi C, Goodwin G. Agomelatine versus escitalopram in major depressive disorders: a randomized double-blind, long term study focusing on sleep satisfaction and emotional blunting. Eur Psychiatry. 2011;26(1):P02-24.

Montgomery SA, Kasper S. Severe depression and antidepressants: Focus on a pooled analysis of placebo controlled studies on agomelatine. Int Clin Psychopharmacol. 2007;22:283-91.

Downloads

Published

2017-09-23

How to Cite

Mehta, A. K., Gupta, D. D., Kumar, R., & Sood, A. (2017). Comparative efficacy of agomelatine versus sertraline in major depressive disorder in Himalayan region of India. International Journal of Basic & Clinical Pharmacology, 6(10), 2358–2365. https://doi.org/10.18203/2319-2003.ijbcp20174359

Issue

Section

Original Research Articles