• Fadhil A-Hamad Saleh-Arong Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine
  • Nattaphon Chokemaitree Department of Psychiatry and Neurology, Phramongkutklao Hospital and College of Medicine
  • Naowanit Nata Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine
  • Pamila Tasanavipas Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine
  • Narittaya Varothai Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine
  • Bancha Satirapoj Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and Phramongkutklao College of Medicine
Keywords: Major depressive disorders, Chronic kidney disease, Depression,, Agomelatine, Sertraline


Background: Depression is highly prevalent and is well known to affect patients with chronic kidney disease (CKD). Agomelatine exerts psychotropic effects upon mood and anxious states. There is limited data on agomelatine treatment among patients with CKD.

Methods: Patients with CKD stage 3-5 with DSM-5-defined major depressive disorder (MDD) were randomly assigned to receive 25 mg/day of agomelatine or sertraline 50 mg/day for eight weeks at Phramongkutklao Hospital. Hamilton Depression Rating Scale (HDRS) score and concerning adverse events were measured at baseline and the end of the study. Efficacy assessment compared the improvements in clinical response and remission between the agomelatine and placebo groups.

Results: Of 53 enrolled patients, 27 were assigned to the agomelatine group and 26 to the sertraline group. The mean age was 64.8±13.4 years. Baseline characteristics were comparable across treatment groups. After eight weeks, agomelatine-treated showed reductions in HDRS score from baseline (-15.6 with 95% CI -18.6 to -12.5). A significant difference was observed in the reduced HDRS scores between agomelatine and sertraline groups (-12.4; 95% CI -18.4 to -6.5). Over the 6-week treatment period, clinical response (55.0 vs. 9.0%, p <0.001) and remission (45.0 vs. 17.4%, p =0.049) improved significantly more with agomelatine than with sertraline. Both agomelatine and sertraline were well-tolerated during the treatment period.

Conclusion: Agomelatine showed superior antidepressant efficacy over sertraline in treating CKD patients with depression after eight weeks, with a good tolerability profile.


Download data is not yet available.


Seidel UK, Gronewold J, Volsek M, Todica O, Kribben A, Bruck H, et al. Physical, cognitive and emotional factors contributing to quality of life, functional health and participation in community dwelling in chronic kidney disease. PLoS One 2014; 9: e91176. DOI: https://doi.org/10.1371/journal.pone.0091176

Shirazian S, Grant CD, Aina O, Mattana J, Khorassani F, Ricardo AC. Depression in Chronic Kidney Disease and End-Stage Renal Disease: Similarities and Differences in Diagnosis, Epidemiology, and Management. Kidney Int Rep 2017; 2: 94-107. DOI: https://doi.org/10.1016/j.ekir.2016.09.005

Hedayati SS, Minhajuddin AT, Afshar M, Toto RD, Trivedi MH, Rush AJ. Association between major depressive episodes in patients with chronic kidney disease and initiation of dialysis, hospitalization, or death. JAMA. 2010; 303: 1946-53. DOI: https://doi.org/10.1001/jama.2010.619

Tsai YC, Chiu YW, Hung CC, Hwang SJ, Tsai JC, Wang SL, et al. Association of symptoms of depression with progression of CKD. Am J Kidney Dis. 2012; 60: 54-61. DOI: https://doi.org/10.1053/j.ajkd.2012.02.325

Kop WJ, Seliger SL, Fink JC, Katz R, Odden MC, Fried LF, et al. Longitudinal association of depressive symptoms with rapid kidney function decline and adverse clinical renal disease outcomes. Clin J Am Soc Nephrol 2011; 6: 834-44. DOI: https://doi.org/10.2215/CJN.03840510

Nagler EV, Webster AC, Vanholder R, Zoccali C. Antidepressants for depression in stage 3-5 chronic kidney disease: a systematic review of pharmacokinetics, efficacy and safety with recommendations by European Renal Best Practice (ERBP). Nephrol Dial Transplant 2012; 27: 3736-45. DOI: https://doi.org/10.1093/ndt/gfs295

Palmer SC, Natale P, Ruospo M, Saglimbene VM, Rabindranath KS, Craig JC, et al. Antidepressants for treating depression in adults with end-stage kidney disease treated with dialysis. Cochrane Database Syst Rev 2016; 23: CD004541. DOI: https://doi.org/10.1002/14651858.CD004541.pub3

Guaiana G, Gupta S, Chiodo D, Davies SJ, Haederle K, Koesters M. Agomelatine versus other antidepressive agents for major depression. Cochrane Database Syst Rev. 2013; 17: CD008851. DOI: https://doi.org/10.1002/14651858.CD008851.pub2

Chen JW, Xie SQ. Agomelatine versus paroxetine in treating depressive and anxiety symptoms in patients with chronic kidney disease. Neuropsychiatr Dis Treat 2018; 14: 547-52. DOI: https://doi.org/10.2147/NDT.S159636

A-Hamad Saleh-Arong F, Trisukon W, Chokemaitree N, Rungprai D, Chaiprasert A, Nata N, et al. Effect of Agomelatine and Sertraline on Major Depressive Disorders among Patients with Chronic Kidney Disease: a Randomized Controlled Trial. Nephrology (Carlton). 2021;26:23.

Wakefield JC. DSM-5: proposed changes to depressive disorders. Curr Med Res Opin 2012; 28: 335-43. DOI: https://doi.org/10.1185/03007995.2011.653436

Satthapisit S, Posayaanuwat N, Sasaluksananont C, Kaewpornsawan T, Singhakun S. The comparison of Montgomery and Asberg Depression Rating Scale (MADRS thai) to diagnostic and statistical manual of mental disorders (DSM) and to Hamilton Rating Scale for Depression (HRSD): validity and reliability. J Med Assoc Thai 2007; 90: 524-31.

Kennedy SH, Avedisova A, Belaidi C, Picarel-Blanchot F, de Bodinat C. Sustained efficacy of agomelatine 10 mg, 25 mg, and 25-50 mg on depressive symptoms and functional outcomes in patients with major depressive disorder. A placebo-controlled study over 6 months. Eur Neuropsychopharmacol 2016; 26: 378-89. DOI: https://doi.org/10.1016/j.euroneuro.2015.09.006

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16: 606-13. DOI: https://doi.org/10.1046/j.1525-1497.2001.016009606.x

Naumann VJ, Byrne GJ. WHOQOL-BREF as a measure of quality of life in older patients with depression. Int Psychogeriatr 2004; 16: 159-73. DOI: https://doi.org/10.1017/S1041610204000109

Hedayati SS, Yalamanchili V, Finkelstein FO. A practical approach to the treatment of depression in patients with chronic kidney disease and end-stage renal disease. Kidney Int 2012; 81: 247-55. DOI: https://doi.org/10.1038/ki.2011.358

Hedayati SS, Gregg LP, Carmody T, Jain N, Toups M, Rush AJ, et al. Effect of Sertraline on depressive symptoms in patients with chronic kidney disease without dialysis dependence: the CAST randomized clinical trial. JAMA 2017; 318: 1876-90. DOI: https://doi.org/10.1001/jama.2017.17131

Friedli K, Guirguis A, Almond M, Day C, Chilcot J, Da Silva-Gane M, et al. Sertraline versus placebo in patients with major depressive disorder undergoing hemodialysis: a randomized, controlled feasibility trial. Clin J Am Soc Nephrol 2017; 12: 280-6. DOI: https://doi.org/10.2215/CJN.02120216

Kang R, He Y, Yan Y, Li Z, Wu Y, Guo X, et al. Comparison of paroxetine and agomelatine in depressed type 2 diabetes mellitus patients: a double-blind, randomized, clinical trial. Neuropsychiatr Dis Treat 2015; 11: 1307-11. DOI: https://doi.org/10.2147/NDT.S85711

Karaiskos D, Tzavellas E, Ilias I, Liappas I, Paparrigopoulos T. Agomelatine and sertraline for the treatment of depression in type 2 diabetes mellitus. Int J Clin Pract 2013; 67: 257-60. DOI: https://doi.org/10.1111/ijcp.12112

Gahr M. Agomelatine in the treatment of major depressive disorder: an assessment of benefits and risks. Curr Neuropharmacol 2014; 12: 287-398. DOI: https://doi.org/10.2174/1570159X12999140619122914

Plesnicar BK. Efficacy and tolerability of agomelatine in the treatment of depression. Patient Prefer Adherence 2014; 8: 603-12. DOI: https://doi.org/10.2147/PPA.S42789

Ghosh A, Hellewell JS. A review of the efficacy and tolerability of agomelatine in the treatment of major depression. Expert Opin Investig Drugs. 2007; 16: 1999-2004. DOI: https://doi.org/10.1517/13543784.16.12.1999

Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs 2010; 24: 479-99. DOI: https://doi.org/10.2165/11534420-000000000-00000

Kasper S, Corruble E, Hale A, Lemoine P, Montgomery SA, Quera-Salva MA. Antidepressant efficacy of agomelatine versus SSRI/SNRI: results from a pooled analysis of head-to-head studies without a placebo control. Int Clin Psychopharmacol 2013; 28: 12-9. DOI: https://doi.org/10.1097/YIC.0b013e328359768e

Gorwood P, Benichou J, Moore N, Wattez M, Secouard MC, Desobry X, et al. Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France. Clin Drug Investig 2020; 40: 1009-20. DOI: https://doi.org/10.1007/s40261-020-00957-9

Geddes JR, Carney SM, Davies C, Furukawa TA, Kupfer DJ, Frank E, et al. Relapse prevention with antidepressant drug treatment in depressive disorders: a systematic review. Lancet 2003; 361: 653-61. DOI: https://doi.org/10.1016/S0140-6736(03)12599-8

How to Cite
A-Hamad Saleh-Arong F, Chokemaitree N, Nata N, Tasanavipas P, Varothai N, Satirapoj B. EFFECT OF AGOMELATINE AND SERTRALINE ON PATIENTS WITH MAJOR DEPRESSIVE DISORDERS AND CHRONIC KIDNEY DISEASE: A RANDOMIZED CONTROLLED TRIAL. J Southeast Asian Med Res [Internet]. 2022Oct.5 [cited 2022Nov.30];60:e0127. Available from: https://www.jseamed.org/index.php/jseamed/article/view/127
Original Articles