Efficacy of agomelatine in major depressive disorder: Meta-analysis and appraisal

International Journal of Neuropsychopharmacology

Volumn 15, Issue 3, 2012, Pages 417-428

  Singh, Surendra P ^a   Singh, Vidhi ^b   Kar, Nilamadhab ^c  

^a UNIVERSITY OF WOLVERHAMPTON   (United Kingdom)

^b MediWare Computer Software Engineering   (United Kingdom)

^c NATIONAL HEALTH SERVICE   (United Kingdom)

Author keywords

Agomelatine; antidepressant; major depressive disorder; meta analysis

Indexed keywords

AGOMELATINE; FLUOXETINE; MELATONIN; PAROXETINE; PLACEBO; SERTRALINE; VENLAFAXINE; ACETAMIDE DERIVATIVE; ANTIDEPRESSANT AGENT;

BODY WEIGHT DISORDER; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; HUMAN; LIVER DYSFUNCTION; MAJOR DEPRESSION; META ANALYSIS; MONOAMINERGIC SYSTEM; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; SEXUAL DYSFUNCTION; SYSTEMATIC REVIEW; TREATMENT OUTCOME; ANIMAL; DEPRESSIVE DISORDER, MAJOR;

ACETAMIDES; ANIMALS; ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84863378679     PISSN: 14611457     EISSN: 14695111     Source Type: Journal    
DOI: 10.1017/S1461145711001301     Document Type: Review

References (75)

1. APA (2000). DSM-IV-TR: Diagnostic and Statistical Manual of Mental Disorders, 4th edn. Washington, DC: American Psychiatric Press Inc.
2. APA (2008). Mood disorders measures. In : Rush AJ, First MB, Blacker D (Eds), Handbook of Psychiatric Measures (pp. 499-528). Washington, DC: American Psychiatric Press.
3. De Berardis D, Di Iorio G, Acciavatti T, Conti C, et al. (2011). The emerging role of melatonin agonists in the treatment of major depression: focus on agomelatine. CNS and Neurological Disorders Drug Targets 10, 119-132.
4. De Bodinat C, Guardiola-Lemaitre B, Mocaër E, Renard P, et al. (2010). Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nature Reviews Drug Discovery 9, 628-642.
5. Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, et al. (2005). Effects of exogenous melatonin on sleep : A meta-analysis. Sleep Medicine Reviews 9, 41-50. (Pubitemid 40092917)
6. Van Buuren S, Groothuis-Oudshoorn K (2010). MICE: Multivariate Imputation by Chained Equations in R. Leiden: Department of Statistics, TNO Quality of Life (http://web.inter.nl.net/users/S.van.Buuren/mi/hmtl/mice.htm).
7. Claustrat B, Brun J, Chazot G (2005). The basic physiology and pathophysiology of melatonin. Sleep Medicine Reviews 9, 11-24. (Pubitemid 40092915)
8. Cooper H (2009). The Handbook of Research Synthesis and Meta-Analysis, 2nd edn. New York: Russell Sage Foundation.
9. Danilenko KV, Putilov AA (2005). Melatonin treatment of winter depression following total sleep deprivation: waking EEG and mood correlates. Neuropsychopharmacology 30, 1345-1352. (Pubitemid 40848088)
10. Dolberg OT, Hirschmann S, Grunhaus L (1998). Melatonin for the treatment of sleep disturbances in major depressive disorder. American Journal of Psychiatry 155, 1119-1121. (Pubitemid 28357744)
11. EMEA (2007). Assessment report for circadin. Evaluation of medicines for human use (http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Scientific- Discussion/human/000695/WC500026808.pdf). Accessed 5 April 2011.
12. EMEA (2009). Agomelatine : summary of product characteristics. Product information (http://www.ema. europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/000915/WC500046227.pdf). Accessed 3 April 2011.
13. Epperson CN, Terman M, Terman JS, Hanusa BH, et al. (2004). Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings. Journal of Clinical Psychiatry 65, 421-425.
14. Eser D, Baghai TC, Mö ller H-J (2010). Agomelatine : the evidence for its place in the treatment of depression. Core Evidence 4, 171-179.
15. Fornaro M, Prestia D, Colicchio S, Perugi G (2010). A systematic, updated review on the antidepressant agomelatine focusing on its melatonergic modulation. Current Neuropharmacology 8, 287-304.
16. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, et al. (2010). Antidepressant drug effects and depression severity : A patient-level meta-analysis. Journal of the American Medical Association 303, 47-53.
17. Di Giannantonio M, Di Iorio G, Guglielmo R, De Berardis D, et al. (2011). Major depressive disorder, anhedonia and agomelatine : An open-label study. Journal of Biological Regulators and Homeostatic Agents 25, 109-114.
18. Goel N, Terman M, Terman JS, Macchi MM, et al. (2005). Controlled trial of bright light and negative air ions for chronic depression. Psychological Medicine 35, 945-955. (Pubitemid 41015693)
19. Goodwin GM (2009). Clinical studies on the efficacy of agomelatine on depressive symptoms. CNS Drugs 23 (Suppl. 2), 35-39.
20. Goodwin GM, Emsley R, Rembry S, Rouillon F (2009). Agomelatine prevents relapse in patients with major depressive disorder without evidence of a discontinuation syndrome: A 24-week randomized, double-blind, placebo-controlled trial. Journal of Clinical Psychiatry 70, 1128-1137.
21. Green B (2011). Focus on agomelatine. Current Medical Research and Opinion 27, 745-749.
22. Grunhaus L, Hirschman S, Dolberg OT, Schreiber S, et al. (2001). Coadministration of melatonin and fluoxetine does not improve the 3-month outcome following ECT. Journal of ECT 17, 124-128. (Pubitemid 32545783)
23. Hale A, Corral R-M, Mencacci C, Ruiz JS, et al. (2010). Superior antidepressant efficacy results of agomelatine vs. fluoxetine in severe MDD patients : A randomized, double-blind study. International Clinical Psychopharmacology 25, 305-314.
24. Howland RH (2007). Agomelatine : A novel atypical antidepressant. Journal of Psychosocial Nursing and Mental Health Services 45, 13-17.
25. Jacobsen FM, Sack DA, Wehr TA, Rogers S, et al. (1987). Neuroendocrine response to 5-hydroxytryptophan in seasonal affective disorder. Archives of General Psychiatry 44, 1086-1091. (Pubitemid 18003472)
26. Kasper S, Hajak G, Wulff K, Hoogendijk WJG, et al. (2010). 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. Journal of Clinical Psychiatry 71, 109-120.
27. Kasper S, Hamon M (2009). Beyond the monoaminergic hypothesis: Agomelatine, a new antidepressant with an innovative mechanism of action. World Journal of Biological Psychiatry 10, 117-126.
28. Kellner M, Yassouridis A, Manz B, Steiger A, et al. (1997). Corticotropin-releasing hormone inhibits melatonin secretion in healthy volunteers-a potential link to low-melatonin syndrome in depression? Neuroendocrinology 65, 284-290. (Pubitemid 27152085)
29. Kennedy SH (2009). Agomelatine : efficacy at each phase of antidepressant treatment. CNS Drugs 23 (Suppl. 2), 41-47.
30. Kennedy SH, Emsley R (2006). Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. European Neuropsychopharmacology 16, 93-100. (Pubitemid 43145814)
31. Kennedy SH, Rizvi S, Fulton K, Rasmussen J (2008). A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. Journal of Clinical Psychopharmacology 28, 329-333.
32. Kennedy SH, Rizvi SJ (2010). Agomelatine in the treatment of major depressive disorder : potential for clinical effectiveness. CNS Drugs 24, 479-499.
33. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, et al. (2008). Initial severity and antidepressant benefits: A meta-analysis of data submitted to the food and drug administration. PLoS Medicine 5, e45.
34. Koorengevel KM, Gordijn MC, Beersma DG, Meesters Y, et al. (2001). Extraocular light therapy in winter depression: A double-blind placebo-controlled study. Biological Psychiatry 50, 691-698. (Pubitemid 33043772)
35. Lam RW (2008). Addressing circadian rhythm disturbances in depressed patients. Journal of Psychopharmacology (Oxford, England) 22, 13-18.
36. Lam RW (2010). The importance of early symptom relief in antidepressant treatment: focus on agomelatine. Journal of Psychopharmacology (Oxford, England) 24, 27-30.
37. Landolt HP, Meier V, Burgess HJ, Finelli LA, et al. (1999). Serotonin-2 receptors and human sleep : effect of a selective antagonist on EEG power spectra. Neuropsychopharmacology 21, 455-466. (Pubitemid 29333084)
38. Lemoine P, Guilleminault C, Alvarez E (2007). Improvement in subjective sleep in major depressive disorder with a novel antidepressant, agomelatine: randomized, double-blind comparison with venlafaxine. Journal of Clinical Psychiatry 68, 1723-1732. (Pubitemid 350247502)
39. Leppämäki S, Partonen T, Vakkuri O, Lönnqvist J, et al. (2003). Effect of controlled-release melatonin on sleep quality, mood, and quality of life in subjects with seasonal or weather-associated changes in mood and behaviour. European Neuropsychopharmacology 13, 137-145. (Pubitemid 36506922)
40. Lerner A, Case J, Takahashi Y, Lee T, et al. (1958). Isolation of melatonin, a pineal factor that lightens melanocytes. Journal of American Chemical Society 80, 2587.
41. Lewy AJ, Bauer VK, Cutler NL, Sack RL (1998). Melatonin treatment of winter depression: A pilot study. Psychiatry Research 77, 57-61. (Pubitemid 28105840)
42. Lieverse R, Van Someren EJW, Nielen MMA, Uitdehaag BMJ, et al. (2011). Bright light treatment in elderly patients with nonseasonal major depressive disorder : A randomized placebo-controlled trial. Archives of General Psychiatry 68, 61-70.
43. Lôo H, Daléry J, Macher JP, Payen A (2003). Pilot study comparing in blind the therapeutic effect of two doses of agomelatine, melatonin-agonist and selective 5HT2c receptors antagonist, in the treatment of major depressive disorders. L'Encéphale 29, 165-171. (Pubitemid 36565983)
44. Lôo H, Hale A, D'haenen H (2002). Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder : A placebo-controlled dose range study. International Clinical Psychopharmacology 17, 239-247.
45. Loving RT, Kripke DF, Elliott JA, Knickerbocker NC, et al. (2005). Bright light treatment of depression for older adults [ISRCTN55452501]. BMC Psychiatry 5, 41.
46. Lu WZ, Gwee KA, Moochhalla S, Ho KY (2005). Melatonin improves bowel symptoms in female patients with irritable bowel syndrome: A double-blind placebo-controlled study. Alimentary Pharmacology and Therapeutics 22, 927-934. (Pubitemid 41634873)
47. Masson-Pévet M, Recio J, Guerrero HY, Mocaer E, et al. (1998). Effects of two melatonin analogues, s-20098 and s-20928, on melatonin receptors in the pars tuberalis of the rat. Journal of Pineal Research 25, 172-176. (Pubitemid 28430597)
48. Millan MJ, Gobert A, Lejeune F, Dekeyne A, et al. (2003). 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. Journal of Pharmacology and Experimental Therapeutics 306, 954-964. (Pubitemid 37025301)
49. Millan MJ, Marin P, Kamal M, Jockers R, et al. (2010). The melatonergic agonist and clinically active antidepressant, agomelatine, is a neutral antagonist at 5-HT2C receptors. International Journal of Neuropsychopharmacology 14, 768-783.
50. Montgomery SA, Kennedy SH, Burrows GD, Lejoyeux M, et al. (2004). Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with paroxetine: A randomized, double-blind, placebo-controlled discontinuation study. International Clinical Psychopharmacology 19, 271-280. (Pubitemid 39141943)
51. Montgomery SA, Kasper S (2007). Severe depression and antidepressants : focus on a pooled analysis of placebo-controlled studies on agomelatine. International Clinical Psychopharmacology 22, 283-291. (Pubitemid 47237547)
52. NICE (2004). National Institute for Health and Clinical Excellence. NICE Guidance (http://www.nice.org.uk/nicemedia/pdf/cg023fullguideline.pdf). Accessed 3 April 2011.
53. Nordlund JJ, Lerner AB (1977). The effects of oral melatonin on skin color and on the release of pituitary hormones. Journal of Clinical Endocrinology and Metabolism 45, 768-774. (Pubitemid 8212527)
54. Olié JP, Kasper S (2007). Efficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorder. International Journal of Neuropsychopharmacology 10, 661-673. (Pubitemid 47517525)
55. Pa?̈zanis E, Renoir T, Lelievre V, Saurini F, et al. (2010). Behavioural and neuroplastic effects of the new-generation antidepressant agomelatine compared to fluoxetine in glucocorticoid receptor-impaired mice. International Journal of Neuropsychopharmacology 13, 759-774.
56. Papp M, Gruca P, Boyer P-A, Mocaër E (2003). Effect of agomelatine in the chronic mild stress model of depression in the rat. Neuropsychopharmacology 28, 694-703.
57. Pjrek E, Winkler D, Konstantinidis A, Willeit M, et al. (2007). Agomelatine in the treatment of seasonal affective disorder. Psychopharmacology 190, 575-579. (Pubitemid 46204474)
58. Popoli M (2009). Agomelatine : innovative pharmacological approach in depression. CNS Drugs 23 (Suppl. 2), 27-34.
59. R Development Core Team (2011). R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing (http://www. r-project.org/). Accessed 2 April 2011.
60. Rosen RC, Lane RM, Menza M (1999). Effects of SSRIs on sexual function : A critical review. Journal of Clinical Psychopharmacology 19, 67-85. (Pubitemid 29047334)
61. Rosenthal DR (1991). Meta-Analytic Procedures for Social Research, revised edn. Newbury Park: Sage Publications Inc.
62. San L, Arranz B (2008). Agomelatine : A novel mechanism of antidepressant action involving the melatonergic and the serotonergic system. European Psychiatry 23, 396-402.
63. Serfaty MA, Osborne D, Buszewicz MJ, Blizard R, et al. (2010). A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood. International Clinical Psychopharmacology 25, 132-142.
64. Serretti A, Chiesa A (2009). Treatment-emergent sexual dysfunction related to antidepressants : A meta-analysis. Journal of Clinical Psychopharmacology 29, 259-266.
65. Singh SP, Singh V, Kar N, Chan K (2010). Efficacy of antidepressants in treating the negative symptoms of chronic schizophrenia : meta-analysis. British Journal of Psychiatry 197, 174-179.
66. Srinivasan V, Brzezinski A, Pandi-Perumal SR, Spence DW, et al. (2011). Melatonin agonists in primary insomnia and depression-associated insomnia: Are they superior to sedative-hypnotics? Progress in Neuro-Psychopharmacology and Biological Psychiatry 35, 913-923.
67. Stahl SM (2007). Novel mechanism of antidepressant action : norepinephrine and dopamine disinhibition (NDDI) plus melatonergic agonism. International Journal of Neuropsychopharmacology 10, 575-578. (Pubitemid 47517528)
68. Stahl SM, Fava M, Trivedi MH, Caputo A, et al. (2010). Agomelatine in the treatment of major depressive disorder : An 8-week, multicenter, randomized, placebo-controlled trial. Journal of Clinical Psychiatry 71, 616-626.
69. Stein DJ, Ahokas AA, de Bodinat C (2008). Efficacy of agomelatine in generalized anxiety disorder : A randomized, double-blind, placebo-controlled study. Journal of Clinical Psychopharmacology 28, 561-566.
70. Viechtbauer W (2005). Bias and efficiency of meta-Analytic variance estimators in the random-Effects model. Journal of Educational and Behavioral Statistics 30, 261-293. (Pubitemid 41538934)
71. Viechtbauer W (2010). Metafor : Meta-Analysis Package for R. Maastricht, The Netherlands: Maastricht University (http://www.wvbauer.com/).
72. WHO (2010). ATC/DDD Index. ATC/DDD Index 2010 (http://www.whocc.no/atc- ddd-index/).
73. Winkley K, Ismail K, Landau S, Eisler I (2006). Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. British Medical Journal (Clinical Research Edition) 333, 65.
74. Wirz-Justice A, Graw P, Kräuchi K, Sarrafzadeh A, et al. (1996). 'Natural' light treatment of seasonal affective disorder. Journal of Affective Disorders 37, 109-120. (Pubitemid 26126294)
75. Zajecka J, Schatzberg A, Stahl S, Shah A, et al. (2010). Efficacy and safety of agomelatine in the treatment of major depressive disorder : A multicenter, randomized, double-blind, placebo-controlled trial. Journal of Clinical Psychopharmacology 30, 135-144.