Agomelatine as monotherapy for major depression: An outpatient, open-label study

Neuropsychiatric Disease and Treatment

Volumn 9, Issue , 2013, Pages 1595-1604

  Pecenak, Jan ^a   Novotny, Vladimir ^a  

^a UNIVERSITY HOSPITAL BRATISLAVA   (Slovakia)

Author keywords

Agomelatine; Depression; Functioning; Monotherapy; Remission

Indexed keywords

AGOMELATINE;

ADULT; AGED; ANXIETY; ARTICLE; CIRCSCREEN SLEEP QUESTIONNAIRE; CLINICAL GLOBAL IMPRESSION SCALE; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FUNCTIONAL STATUS; GLOBAL ASSESSMENT OF FUNCTIONING; HEADACHE; HEART RATE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MONOTHERAPY; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; NIGHTMARE; OPEN STUDY; OUTPATIENT; PHASE 4 CLINICAL TRIAL; QUESTIONNAIRE; REMISSION; SHEEHAN DISABILITY SCALE; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; WEIGHT CHANGE;

EID: 84886021041     PISSN: 11766328     EISSN: 11782021     Source Type: Journal    
DOI: 10.2147/NDT.S49062     Document Type: Article

References (53)

1. World Health Organization. Depression, a global health concern. Available from: http://www.who.int/mental_health/management/depression/who_paper_depression_wfmh_2012.pdf. Accessed September 6, 2013.
2. World Health Organization. The global burden of disease: 2004 update. Available from: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/. Accessed September 6, 2013.
3. Barlow DH. Abnormal Psychology: An Integrative Approach. 5th ed. Belmont, CA: Thomson Wadsworth; 2005.
4. Klerman GN, Weisman MM. The course, morbidity and costs of depression. Arch Gen Psychiatry. 1992;49(10):831-834.
5. Prien RF, Kocsis JH. Long-term treatment of mood disorders. In: Bloom FE, Kupfer DJ, editors. Psychopharmacology: the Fourth Generation of Progress. American College of Neuropsychopharmacology; 2008. Available from: http://www.acnp.org/g4/GN401000104/CH102.html. Accessed September 6, 2013.
6. Khawam EA, Laurencic G, Malone D Jr. Side effects of antidepressants-an overview. Cleve Clin J Med. 2006;73(4):351-361.
7. DeBattista C. Antidepressant Agents. In: Katzung BG, Masters SB, Trevor AJ, editors. Basic and Clinical Pharmacology. New Delhi, India: Tata McGraw Hill Education Private Ltd; 2009;521-542.
8. Llorca PM. The antidepressant agomelatine improves the quality of life of depressed patients: implications for remission. J Psychopharmacol. 2010;24 Suppl 2:21-26.
9. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40.
10. Clayton AH, Favit A. Concerns in depression treatment. Prim Psychiatry. 2007;14(6):66-67.
11. de Bodinat C, Guardiola-Lemaitre B, Mocaër E, Renard P, Muñoz C, Millan MJ. Agomelatine-the first melatogenic antidepressant, discovery, characterization and development. Nat Rev Drug Discov. 2010;9(8):628-642.
12. Loo H, Hale A, D'haenen H. Determination of the dose of agomelatine, a melatonergic agonist and selective 5-HT2C antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study. Int Clin Psychopharmacol. 2002;17(5):239-247.
13. Kennedy SH, Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol. 2006;16(2):93-100.
14. Goodwin GM, Emsley R, Rembry S, Rouillon F; for Agomelatine Study Group. Agomelatine prevents relapse in patients with major depressive disorder without evidence of a discontinuation syndrome: a 24-week randomized, double-blind, placebo-controlled trial. Clin Psychiatry. 2009;70(8):1128-1137.
15. Zajecka J, Schatzberg A, Stahl S, Shah A, Caputo A, Post A. Efficacy and safety of agomelatine in the treatment of major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2010;30(2):135-144.
16. Olié 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(5):661-673.
17. Kennedy SH, Rizvi 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(3):329-333.
18. 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(11):1723-1732.
19. Laux G; the VIVALDI Study Group. The antidepressant agomelatine in daily practice: results of the non-interventional study VIVALDI. Pharmacopsychiatry. 2012;45(7):284-291.
20. Racagni G, Riva MA, Molteni R, et al. Mode of action of agomelatine-synergy between melatonergic and 5 HT2C receptors. World J Biol Psychiatry. 2011;12(8):574-587.
21. Chenu F, El Mansari M, Blier P, et al. Electrophysiological effects of repeated administration of agomelatine on the dopamine, norepinephrine, and serotonin systems in the rat brain. Neuropsychopharmacology. 2013;38(2):275-278.
22. Pompili M, Serafini G, Innamorati M, et al. Agomelatine, a novel intriguing antidepressant option enhancing neuroplasticity: a critical review. World J Biol Psychiatry. 2013;14(6):412-431.
23. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Press; 2000.
24. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33.
25. Montgomery SA, Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382-389.
26. Riedel M, Möller HJ, Obermeier M, et al. Response and remission criteria in major depression-a validation of current practice. J Psychiatr Res. 2010;44:1063-1068.
27. Guy W, editor. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration; 1976.
28. Global Assessment of Functioning (GAF) Scale. Available from: https://www.msu.edu/course/sw/840/stocks/pack/axisv.pdf. Accessed September 6, 2013.
29. Sheehan DV. Sheehan Disability Scale. In: American Psychiatric Association. Handbook of Psychiatric Measures. Washington, DC: American Psychiatric Publishing Inc; 2000.
30. Laredo J, Quera-Salva MA, Flissard B, de Bodinat C. Screening of sleep and circadian rhythms in major depression. J Sleep Res. 2002;11 Suppl 1:132-133.
31. European Medicine Agency. Agomelatine. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/000915/WC500046227.pdf. Accessed May 14, 2013.
32. Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs. 2010;24(6):479-499.
33. Kennedy SH, Eisfeld BS. Agomelatine and its therapeutic potential in the depressed patient. Neuropsychiatr Dis Treat. 2007;3(4):423-428.
34. Montgomery SA, Kasper S. Severe depression and antidepressants: focus on a pooled analysis of placebo-controlled studies on agomelatine. Int Clin Psychopharmacol. 2007;22(5):283-291.
35. Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol. 2006;16(2):93-10.
36. 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):616-626.
37. Carney RM, Shelton RC. Agomelatine for the treatment of major depressive disorder. Expert Opin Pharmacother. 2011;12(15):2411-2419.
38. Howland RH. Critical appraisal and update on the clinical utility of agomelatine, a melatonergic agonist, for the treatment of major depressive disease in adults. Neuropsychiatr Dis Treat. 2009;5:563-576.
39. Rouillon F. Efficacy and tolerance profile of agomelatine and practical use in depressed patients. Int Clin Psychopharmacol. 2006;21 Suppl 1: S31-S35.
40. Lam RW. The importance of early symptom relief in antidepressant treatment: focus on agomelatine. J Psychopharmacol. 2010;24 Suppl 2:27-30.
41. Ciudad A, Álvarez E, Roca M, et al. Early response and remission as predictors of a good outcome of a major depressive episode at 12-month follow-up: a prospective, longitudinal, observational study. J Clin Psychiatry. 2012;73(2):185-191.
42. 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. Int Clin Psychopharmacol. 2010;25(6):305-314.
43. Di Giannantonio M, Di Iorio G, Guglielmo R, et al. Major depressive disorder, anhedonia and agomelatine: an open-label study. J Biol Regul Homeost Agents. 2011;25(1):109-114.
44. Mitchell AJ. Two-week delay in onset of action of antidepressants: new evidence. Br J Psychiatry. 2006;188:105-106.
45. Krishnan V, Nestler EJ. Linking molecules to mood: new insight into the biology of depression. Am J Psychiatry. 2010;167(11):1305-1320.
46. Machado-Vieira R, Salvadore G, Luckenbaugh DA, Manji HK, Zarate CA Jr. Rapid onset of antidepressant action: a new paradigm in the research and treatment of major depressive disorder. J Clin Psychiatry. 2008;69(6):946-958.
47. De Fruyt J, Demyttenaere K. Quality of life measurement in antidepressant trials. Is there an added value? Psychother Psychosom. 2009;78(4): 212-219.
48. Roy-Byrne P, Dagadakis C, Unutzer J, Ries R. Evidence for limited validity of the revised global assessment of functioning scale. Psychiatr Serv. 1996;47(8):864-866.
49. Bech P. Social functioning: should it become an endpoint in trials of antidepressants? CNS Drugs. 2005;19(4):313-324.
50. McIntyre RS, Park KY, Law CW, et al. The association between conventional antidepressants and the metabolic syndrome: a review of the evidence and clinical implications. CNS Drugs. 2010;24(9):741-753.
51. Naudet F, Maria AS, Falissard B. Antidepressant response in major depressive disorder: a meta-regression comparison of randomized controlled trials and observational studies. PLoS One. 2011;6(6):e20811.
52. Healy D. The assessment of outcomes in depression: measures of social functioning. Rev Contemp Pharmacother. 2000;11(5):295-301.
53. Hickie IB, Rogers NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet. 2011;378(9791): 621-631.