Hostname: page-component-848d4c4894-p2v8j Total loading time: 0 Render date: 2024-04-30T20:29:05.525Z Has data issue: false hasContentIssue false
  • English
  • Français

Effect of agomelatine treatment on C-reactive protein levels in patients with major depressive disorder: an exploratory study in “real-world,” everyday clinical practice

Published online by Cambridge University Press:  05 October 2016

Domenico De Berardis ,
Michele Fornaro ,
Laura Orsolini ,
Felice Iasevoli ,
Carmine Tomasetti ,
Andrea de Bartolomeis ,
Nicola Serroni ,
Ida De Lauretis ,
Gabriella Girinelli  and
Monica Mazza
...Show all authors
Domenico De Berardis*
Affiliation:
National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, Teramo, Italy Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
Michele Fornaro
Affiliation:
New York Psychiatric Institute, Columbia University, New York, New York, USA Polyedra, Teramo, Italy
Laura Orsolini
Affiliation:
Polyedra, Teramo, Italy School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK Villa S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, Italy
Felice Iasevoli
Affiliation:
Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, Naples, Italy
Carmine Tomasetti
Affiliation:
Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, Naples, Italy
Andrea de Bartolomeis
Affiliation:
Laboratory of Molecular Psychiatry and Psychopharmacotherapeutics, Section of Psychiatry, Department of Neuroscience, University School of Medicine “Federico II”, Naples, Italy
Nicola Serroni
Affiliation:
Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
Ida De Lauretis
Affiliation:
Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
Gabriella Girinelli
Affiliation:
Polyedra, Teramo, Italy
Monica Mazza
Affiliation:
Department of Health Science, University of L’Aquila, L’Aquila, Italy
Alessandro Valchera
Affiliation:
Polyedra, Teramo, Italy Villa S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, Italy
Alessandro Carano
Affiliation:
National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “Madonna Del Soccorso”, San Benedetto del Tronto, Ascoli Piceno, Italy
Federica Vellante
Affiliation:
National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, Teramo, Italy Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy Polyedra, Teramo, Italy
Ilaria Matarazzo
Affiliation:
National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, Teramo, Italy Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
Giampaolo Perna
Affiliation:
Hermanas Hospitalarias, FoRiPsi, Department of Clinical Neurosciences, Villa San Benedetto Menni, Albese con Cassano, Como, Italy Department of Psychiatry and Neuropsychology, University of Maastricht, Maastricht, The Netherlands Department of Psychiatry and Behavioral Sciences, Leonard Miller School of Medicine, University of Miami, Miami, Florida, USA
Giovanni Martinotti
Affiliation:
Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
Massimo Di Giannantonio
Affiliation:
Department of Neurosciences and Imaging, Chair of Psychiatry, University “G. D’Annunzio”, Chieti, Italy
*
*Address for correspondence: Domenico De Berardis, MD, PhD, National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, “G. Mazzini” Hospital, p.zza Italia 1, 64100 Teramo, Italy. (Email: dodebera@alice.it)
Get access Rights & Permissions [Opens in a new window]

Abstract

Objective

Agomelatine is a newer antidepressant but, to date, no studies have been carried out investigating its effects on C-reactive protein (CRP) levels in major depressive disorder (MDD) before and after treatment. The present study aimed (i) to investigate the effects of agomelatine treatment on CRP levels in a sample of patients with MDD and (ii) to investigate if CRP variations were correlated with clinical improvement in such patients.

Methods

30 adult outpatients (12 males, 18 females) with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of MDD were recruited in “real-world,” everyday clinical practice and treated with a flexible dose of agomelatine for 12 weeks. The Hamilton Rating Scale for Depression (HAM-D) and the Snaith-Hamilton Pleasure Scale (SHAPS) were used to evaluate depressive symptoms and anhedonia, respectively. Moreover, serum CRP was measured at baseline and after 12 weeks of treatment.

Results

Agomelatine was effective in the treatment of MDD, with a significant reduction in HAM-D and SHAPS scores from baseline to endpoint. CRP levels were reduced in the whole sample, with remitters showing a significant difference in CRP levels after 12 weeks of agomelatine. A multivariate stepwise linear regression analysis showed that higher CRP level variation was associated with higher baseline HAM-D scores, controlling for age, gender, smoking, BMI, and agomelatine dose.

Conclusions

Agomelatine’s antidepressant properties were associated with a reduction in circulating CRP levels in MDD patients who achieved remission after 12 weeks of treatment. Moreover, more prominent CRP level variation was associated with more severe depressive symptoms at baseline.

Keywords

AgomelatineanhedoniaC-reactive proteininflammationmajor depressive disorderremissionresponse
Type
Original Research
Information
CNS Spectrums , Volume 22 , Issue 4 , August 2017 , pp. 342 - 347
Copyright
© Cambridge University Press 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Ferrari, AJ, Charlson, FJ, Norman, RE, et al. Burden of depressive disorders by country, sex, age, and year: findings from the Global Burden of Disease study 2010. PLoS Med. 2013; 10(11): e100154.Google Scholar
2. Kessler, RC, Berglund, P, Demler, O, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003; 289(23): 3095–3105.Google Scholar
3. Miller, AH, Maletic, V, Raison, CL. Inflammation and its discontents: the role of cytokines in the pathophysiology of major depression. Biol Psychiatry. 2009; 65(9): 732–741.CrossRefGoogle ScholarPubMed
4. De Berardis, D, Conti, CM, Campanella, D, et al. Evaluation of C-reactive protein and total serum cholesterol in adult patients with bipolar disorder. Int J Immunopathol Pharmacol. 2008; 21(2): 319–324.CrossRefGoogle ScholarPubMed
5. Dowlati, Y, Herrmann, N, Swardfager, W, et al. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010; 67(5): 446–457.CrossRefGoogle ScholarPubMed
6. Raison, CL, Miller, AH. Role of inflammation in depression: implications for phenomenology, pathophysiology and treatment. Mod Trends Pharmacopsychiatri. 2013; 28: 33–48.CrossRefGoogle Scholar
7. Leonard, BE. Inflammation, depression and dementia: are they connected? Neurochem Res. 2007; 32(10): 1749–1756.Google Scholar
8. Gambi, F, De Berardis, D, Campanella, D, et al. A retrospective evaluation of the inflammatory marker C-reactive protein (CRP), cholesterol and high-density lipoproteins in patients with major depression: preliminary findings. Eur J Inflamm. 2005; 3(3): 127–134.CrossRefGoogle Scholar
9. Lam, RW. Onset, time course and trajectories of improvement with antidepressants. Eur Neuropsychopharmacol. 2012; 22(Suppl 3): S492–S498.Google Scholar
10. Klemettilä, JP, Kampman, O, Seppälä, N, et al. Cytokine and adipokine alterations in patients with schizophrenia treated with clozapine. Psychiatry Res. 2014; 218(3): 277–283.CrossRefGoogle ScholarPubMed
11. Devaraj, S, Valleggi, S, Siegel, D, Jialal, I. Role of C-reactive protein in contributing to increased cardiovascular risk in metabolic syndrome. Curr Atheroscler Rep. 2010; 12(2): 110–118.CrossRefGoogle ScholarPubMed
12. Biggio, G. Neurobiology and pharmacology of a new antidepressant therapy. Journal of Psychopathology. 2011; 17(3): 335–340.Google Scholar
13. De Bodinat, C, Guardiola-Lemaitre, B, Mocaër, E, Renard, P, Muñoz, C, Millan, MJ. Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nat Rev Drug Discov. 2010; 9(8): 628–642.CrossRefGoogle ScholarPubMed
14. Hickie, IB, Rogers, NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet. 2011; 378(9791): 621–631.Google Scholar
15. Fornaro, M, Bandini, F, Cestari, L, et al. Electroretinographic modifications induced by agomelatine: a novel avenue to the understanding of the claimed antidepressant effect of the drug? Neuropsychiatr Dis Treat. 2014; 10: 907–914.Google Scholar
16. De Berardis, D, Di Iorio, G, Acciavatti, T, et al. The emerging role of melatonin agonists in the treatment of major depression: focus on agomelatine. CNS Neurol Disord Drug Targets. 2011; 10(1): 119–132.CrossRefGoogle ScholarPubMed
17. Kennedy, SH, Avedisova, A, Belaïdi, 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(2): 378–389.CrossRefGoogle ScholarPubMed
18. Komaram, RB, Nukala, S, Palla, J, Nambaru, LR, Kasturi, SM. A comparative study of efficacy and safety of agomelatine and escitalopram in major depressive disorder. J Clin Diagn Res. 2015; 9(6): VC05–VC08.Google Scholar
19. Fornaro, M, Prestia, D, Colicchio, S, Perugi, G. A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation. Curr Neuropharmacol. 2010; 8(3): 287–304.Google Scholar
20. Plesničar, BK. Efficacy and tolerability of agomelatine in the treatment of depression. Patient Prefer Adherence. 2014; 8: 603–612.CrossRefGoogle ScholarPubMed
21. First, MB, Spitzer, RL, Gibbon, M, Williams, JBW. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version (SCID-I/P), Patient ed. New York: Biometrics Research; 2002.Google Scholar
22. Hamilton, M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967; 6(4): 278–296.CrossRefGoogle ScholarPubMed
23. Snaith, RP, Hamilton, M, Morley, S, Humayan, A, Hargreaves, D, Trigwell, P. A scale for the assessment of hedonic tone: the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995; 167(1): 99–103.CrossRefGoogle ScholarPubMed
24. Ballenger, JC. Clinical guidelines for establishing remission in patients with depression and anxiety. J Clin Psychiatry. 1999; 60(Suppl 22): 29–34.Google ScholarPubMed
25. Lanquillon, S, Krieg, LC, Bening-Abu-Shach, U, Vedder, H. Cytokine production and treatment response in major depressive disorder. Neuropsychopharmacology. 2000; 22(4): 370–379.Google Scholar
26. Tuglu, C, Kara, SH, Caliyurt, O, Vardar, E, Abay, E. Increased serum tumor necrosis factor-α levels and treatment response in major depressive disorder. Psychopharmacology. 2003; 170(4): 429–433.Google Scholar
27. Uher, R, Tansey, KE, Dew, T, et al. An inflammatory biomarker as a differential predictor of outcome of depression treatment with escitalopram and nortriptyline. Am J Psychiatry. 2014; 171(12): 1278–1286.Google Scholar
28. Eyre, HA, Stuart, MJ, Baune, BT. A phase-specific neuroimmune model of clinical depression. Prog Neuropsychopharmacol Biol Psychiatry. 2014; 54: 265–274.Google Scholar
29. Riedel, M, Möller, HJ, Obermeier, M, et al. Response and remission criteria in major depression—a validation of current practice. J Psychiatr Res. 2010; 44(15): 1063–1068.Google Scholar
30. Tsai, SY, Chung, KH, Huang, SH, Chen, PH, Lee, HC, Kuo, CJ. Persistent inflammation and its relationship to leptin and insulin in phases of bipolar disorder from acute depression to full remission. Bipolar Disord. 2010; 16(8): 800–808.CrossRefGoogle Scholar
31. O’Brien, SM, Scott, LV, Dinan, TG. Antidepressant therapy and C-reactive protein levels. Br J Psychiatry. 2006; 188(5): 449–452.Google Scholar
32. De Berardis, D, Marini, S, Fornaro, M, et al. The melatonergic system in mood and anxiety disorders and the role of agomelatine: implications for clinical practice. Int J Mol Sci. 2013; 14(6): 12458–12483.Google Scholar
33. Kizaki, T, Sato, S, Shirato, K, et al. Effect of circadian rhythm on clinical and pathophysiological conditions and inflammation. Crit Rev Immunol. 2015; 35(4): 261–275.Google Scholar
34. Wright, KP Jr, Drake, AL, Frey, DJ, et al. Influence of sleep deprivation and circadian misalignment on cortisol, inflammatory markers, and cytokine balance. Brain Behav Immun. 2015; 47: 24–34.Google Scholar
35. MacIsaac, SE, Carvalho, AF, Cha, DS, Mansur, RB, McIntyre, RS. The mechanism, efficacy, and tolerability profile of agomelatine. Expert Opin Pharmacother. 2014; 15(2): 259–274.CrossRefGoogle ScholarPubMed
36. Martino, M, Rocchi, G, Escelsior, A, Fornaro, M. Immunomodulation mechanism of antidepressants: interactions between serotonin/norepinephrine balance and Th1/Th2 balance. Curr Neuropharmacol. 2012; 10(2): 97–123.Google Scholar
37. Hashimoto, K. Inflammatory biomarkers as differential predictors of antidepressant response. Int J Mol Sci. 2015; 16(4): 7796–7801.CrossRefGoogle ScholarPubMed