Agomelatin – antidepresivum s novým mechanismem působení

Číslo: 6 / 2010 (Obsah)
Rubrika: Profily léčiv
Obor: Psychiatrie
Autoři: MUDr. Luboš Janů, Ph.D.
MUDr. Sylva Racková, Ph.D.1
Autoři - působiště: Fachklinik Furth im Wald, 1 Psychiatrická klinika LF UK a FN, Plzeň
Klíčová slova: agomelatin, deprese, cirkadiánní rytmy
Citace: 1 EMEA – CHMP Assessment Report for Valdoxan; Procedure No. EMEA/ H/C/000915; www.emea.europa.eu. 2 Švestka J. Agomelatin – nové melatonergní a serotoninergní antidepresivum. Psychiatrie 2005;9:303–10. 3 Audinot V, Mailliet F, Lahaye BC, et al. New selective ligands of human cloned melatonin MT1 and MT2 receptors. Naunyn Schmiedeberg’s Arch Pharmacol 2003;16:553–61. 4 Millan MJ, Gobert A, Lejeune F, et al. The novel melatonin agonist agomelatine (S20098) is an antagonist at 5-hydroxytryptamine 2C receptors, blockade of which enhances the activity of frontocortical dopaminergic and adrenergic pathways. J Pharmacol Exp Therapeut 2003;306:954–64. 5 Hanoun N, Mocaer E, Boyer PA, et al. Differential effects of the novel antidepressant agomelatine (S20098) versus fluoxetine on 5-HT(1A) receptors in the rat brain. Neuropharmacology 2004;47:515–26. 6 Skene DJ, Arendt J. Human circadian rhythms: physiological and therapeutic relevance of light and melatonin. Ann Clin Biochem 2006;43:344–53. 7 Banasr M, Soumier A, Hery M, et al. Agomelatine, a new antidepressant, induces regional changes in hippocampal neurogenesis. Biol Psychiatry 2006;59:1087–96. 8 Conboy L, Tanrikut C, Zoladz PR. The antidepressant agomelatine blocks the adverse effects of stress on memory and enable spatial learning to rapidly increase neural cell adhesion molecule (NCAM) expression in the hippocampus of rats. Int J Neuropsychopharmacol 2009;12:329–41. 9 Kasper S, Hamon M. Beyond the monoaminergic hypothesis: Agomelatine, a new antidepressant with an innovative mechanism of action. World J Biol Psychiatry 2009;10:117–26. 10 Papp M, Gruca P, Boyer PA, et al. Effect of agomelatine in the chronic mild stress model of depression in the rat. Neuropsychopharmacology 2003;28:694–703. 11 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;17:239–47. 12 Loo H, D‘haenen H, Hale A. A double-blind study of S-20098 in patients with major depressive or bipolar II disorders: effect on remission (Abstract). Int J Neuropsychopharmacol 2002; 5(Suppl. 1):145. 13 Stahl SM, Fava M, Trivedi MH, et al. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry 2010;71:616–26. 14 Zajecka J, Schatzberg A, Stahl S, et al. Efficacy and safety of agomelatine in the treatment of major depressive disorder. A multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol 2010;30:135–44. 15 Kennedy SH, Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol 2006;16:93–100. 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;10:661–73. 17 Švestka J, Mohr P. Agomelatin – antidepresivum s novým mechanizmem působení. Psychiatrie 2010;14:98–108. 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;68:1723–32. 19 Kennedy SH, Rizvi S, Fulton K, et al. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J Clin Psychopharmacol 2008;28:329–33. 20 Kasper S, Hajak G, Wulff K, et al. 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. J Clin Psychiatry 2010;71:109–20. 21 Goodwin GM, Emsley R, Rembry S, et al. Agomelatine prevents relapse in patients with major depressive disorder, without evidence of a discontinuation syndrome: a 24-week randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2009;70:1128–37. 22 Kennedy S, Loo H, Olié JP. The antidepressant efficacy of agomelatine is independent of gender, age, body mass index and use of concomitant anxiolytics: combined analysis of three placebo-controlled studies (Abstract). Int J Neuropsychopharmacol 2008;11(Suppl. 1):193. 23 Kennedy SH, Loo H, Olié JP, et al. The efficacy of agomelatine accross distinct clinical populations of depressive patients (Abstract). World Psychiatry 2009;8(Suppl 1):182. 24 de Bodinat C, Guardiola-Lemaitre B, MocaĎr E, et al. Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nat Rev Drug Discov 2010;9:628–42. 25 Quera-Salva MA, Lemoine P, Guilleminault C. Impact of the novel antidepressant agomelatine on disturbed sleep-wake cycles in depressed patients. Hum Psychopharmacol Clin Exp 2010;25:222–9. 26 Stein DJ, Ahokas AA, de Bodinat C. Efficacy of agomelatine in generalized anxiety disorder. A randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008; 28:561–6. 27 Calabrese JR, Guelfi JD, Perdrizet-Chevallier C, and The Agomelatine Bipolar Study Group. Agomelatine adjunctive therapy for acute bipolar depression: preliminary open data. Bipol Disord 2007;9:628–35. 28 Pjrek E, Winkler D, Konstantinidis A, et al. Agomelatine in the treatment of seasonal affective disorder. Psychopharmacology 2007;190:575–9. 29 Kasper S, Hale A, Lemoine P, et al. Superior efficacy results of agomelatine in pooled analysis versus SSRI/SNRI. Abstract ECNP 2010. 30 Montgomery SA, Kennedy SH, Burrows GD, et al. Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with paroxetine: a randomized, doubleblind, placebo-controlled discontinuation study. Int Clin Psychopharmacol 2004;19:271–80. 31 McIntyre RS, Panjwani ZD, Nguyen HT, et al. The hepatic safety profile of duloxetine: A review. Expert Opin Drug Metab Toxicol 2008;4:281–5. 32 Anderson IM, Ferrier IN, Baldwin RC, et al. Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol 2008;22:343–96. 33 Hale A, Corral RM, Mencacci C, et al. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. Int Clin Psychopharmacol 2010;25:305–14. 34 Gorwood P. Restoring circadian rhythms: a new way to successfully manage depression. J Psychopharmacol 2010; 24(Suppl 2):15–9.

Souhrn

Agomelatin je agonista receptorů MT1 a MT2 a antagonista 5-HT2C receptorů. Toto antidepresivum bylo úspěšně srovnáváno s placebem, SSRI i SNRI v léčbě depresivní poruchy. Mezi jeho hlavní přednosti patří rychlý nástup účinku a velmi dobrá snášenlivost. Přínosy pro jiné diagnózy dosud nebyly ověřeny.  „

Literatura

1 EMEA – CHMP Assessment Report for Valdoxan; Procedure No. EMEA/ H/C/000915; www.emea.europa.eu. 2 Švestka J. Agomelatin – nové melatonergní a serotoninergní antidepresivum. Psychiatrie 2005;9:303–10. 3 Audinot V, Mailliet F, Lahaye BC, et al. New selective ligands of human cloned melatonin MT1 and MT2 receptors. Naunyn Schmiedeberg’s Arch Pharmacol 2003;16:553–61. 4 Millan MJ, Gobert A, Lejeune F, et al. The novel melatonin agonist agomelatine (S20098) is an antagonist at 5-hydroxytryptamine 2C receptors, blockade of which enhances the activity of frontocortical dopaminergic and adrenergic pathways. J Pharmacol Exp Therapeut 2003;306:954–64. 5 Hanoun N, Mocaer E, Boyer PA, et al. Differential effects of the novel antidepressant agomelatine (S20098) versus fluoxetine on 5-HT(1A) receptors in the rat brain. Neuropharmacology 2004;47:515–26. 6 Skene DJ, Arendt J. Human circadian rhythms: physiological and therapeutic relevance of light and melatonin. Ann Clin Biochem 2006;43:344–53. 7 Banasr M, Soumier A, Hery M, et al. Agomelatine, a new antidepressant, induces regional changes in hippocampal neurogenesis. Biol Psychiatry 2006;59:1087–96. 8 Conboy L, Tanrikut C, Zoladz PR. The antidepressant agomelatine blocks the adverse effects of stress on memory and enable spatial learning to rapidly increase neural cell adhesion molecule (NCAM) expression in the hippocampus of rats. Int J Neuropsychopharmacol 2009;12:329–41. 9 Kasper S, Hamon M. Beyond the monoaminergic hypothesis: Agomelatine, a new antidepressant with an innovative mechanism of action. World J Biol Psychiatry 2009;10:117–26.
10
Papp M, Gruca P, Boyer PA, et al. Effect of agomelatine in the chronic mild stress model of depression in the rat. Neuropsychopharmacology 2003;28:694–703.
11
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;17:239–47.
12
Loo H, D‘haenen H, Hale A. A double-blind study of S-20098 in patients with major depressive or bipolar II disorders: effect on remission (Abstract). Int J Neuropsychopharmacol 2002; 5(Suppl. 1):145.
13
Stahl SM, Fava M, Trivedi MH, et al. Agomelatine in the treatment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. J Clin Psychiatry 2010;71:616–26.
14
Zajecka J, Schatzberg A, Stahl S, et al. Efficacy and safety of agomelatine in the treatment of major depressive disorder. A multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol 2010;30:135–44.
15
Kennedy SH, Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol 2006;16:93–100.
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;10:661–73.
17
Švestka J, Mohr P. Agomelatin – antidepresivum s novým mechanizmem působení. Psychiatrie 2010;14:98–108.
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;68:1723–32.
19
Kennedy SH, Rizvi S, Fulton K, et al. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J Clin Psychopharmacol 2008;28:329–33.
20
Kasper S, Hajak G, Wulff K, et al. 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. J Clin Psychiatry 2010;71:109–20.
21
Goodwin GM, Emsley R, Rembry S, et al. Agomelatine prevents relapse in patients with major depressive disorder, without evidence of a discontinuation syndrome: a 24-week randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2009;70:1128–37.
22
Kennedy S, Loo H, Olié JP. The antidepressant efficacy of agomelatine is independent of gender, age, body mass index and use of concomitant anxiolytics: combined analysis of three placebo-controlled studies (Abstract). Int J Neuropsychopharmacol 2008;11(Suppl. 1):193.
23
Kennedy SH, Loo H, Olié JP, et al. The efficacy of agomelatine accross distinct clinical populations of depressive patients (Abstract). World Psychiatry 2009;8(Suppl 1):182.
24
de Bodinat C, Guardiola-Lemaitre B, MocaĎr E, et al. Agomelatine, the first melatonergic antidepressant: discovery, characterization and development. Nat Rev Drug Discov 2010;9:628–42.
25
Quera-Salva MA, Lemoine P, Guilleminault C. Impact of the novel antidepressant agomelatine on disturbed sleep-wake cycles in depressed patients. Hum Psychopharmacol Clin Exp 2010;25:222–9.
26
Stein DJ, Ahokas AA, de Bodinat C. Efficacy of agomelatine in generalized anxiety disorder. A randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008; 28:561–6.
27
Calabrese JR, Guelfi JD, Perdrizet-Chevallier C, and The Agomelatine Bipolar Study Group. Agomelatine adjunctive therapy for acute bipolar depression: preliminary open data. Bipol Disord 2007;9:628–35.
28
Pjrek E, Winkler D, Konstantinidis A, et al. Agomelatine in the treatment of seasonal affective disorder. Psychopharmacology 2007;190:575–9.
29
Kasper S, Hale A, Lemoine P, et al. Superior efficacy results of agomelatine in pooled analysis versus SSRI/SNRI. Abstract ECNP 2010.
30
Montgomery SA, Kennedy SH, Burrows GD, et al. Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with paroxetine: a randomized, doubleblind, placebo-controlled discontinuation study. Int Clin Psychopharmacol 2004;19:271–80.
31
McIntyre RS, Panjwani ZD, Nguyen HT, et al. The hepatic safety profile of duloxetine: A review. Expert Opin Drug Metab Toxicol 2008;4:281–5.
32
Anderson IM, Ferrier IN, Baldwin RC, et al. Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol 2008;22:343–96.
33
Hale A, Corral RM, Mencacci C, et al. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. Int Clin Psychopharmacol 2010;25:305–14.
34
Gorwood P. Restoring circadian rhythms: a new way to successfully manage depression. J Psychopharmacol 2010; 24(Suppl 2):15–9.

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