The Antidepressant Agomelatine in Daily Practice: Results of the Non-Interventional Study VIVALDI

 

 Buy Article Permissions and Reprints

Abstract

Introduction:

The non-interventional study VIVALDI was carried out to evaluate the treatment with agomelatine, an innovative antidepressant, in routine practice.

Methods:

665 psychiatrists treated 3 317 patients over 12 weeks with agomelatine and documented antidepressant effects via svMADRS, CGI scale and CircScreen questionnaire. Subgroups with severe depression (svMADRS ≥30) and elderly patients (≥65 years) were also analyzed.

Results:

In the total population, svMADRS total score decreased from 30.6 at baseline to 12.8 at final visit, in severely depressed patients from 36.7 to 14.7, in elderly patients from 29.0 to 12.2. In total 65.8% of patients could be classified as responders (≥50% decrease in svMADRS total score) and 54.8% as remitters (svMADRS ≤12). Daytime sleepiness was ameliorated in 78.2% of patients. Adverse drug reactions were reported for 10.0%, 8.9% and 10.1% of patients in total population, severely ill and elderly patients, respectively.

Discussion:

In this study, the antidepressant effects, improvement of circadian rhythm disorders and good tolerability of agomelatine were observed in unselected depressed patients, including multimorbid elderly and severely depressed patients under routine practice.

• References

• 1 Alonso J, Angermeyer MC, Bernert S et al. Prevalence of mental disorders in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl 2004; 21-27
  PubMedGoogle 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: 3095-3105
  CrossrefPubMedGoogle Scholar
• 3 Sobocki P, Jonsson B, Angst J et al. Cost of depression in Europe. J Ment Health Policy Econ 2006; 9: 87-98
  PubMedGoogle Scholar
• 4 Wehr TA, Wirz-Justice A. Circadian rhythm mechanisms in affective illness and in antidepressant drug action. Pharmacopsychiatria 1982; 15: 31-39
  Article in Thieme ConnectPubMedGoogle Scholar
• 5 Wirz-Justice A. Biological rhythm disturbances in mood disorders. Int Clin Psychopharmacol 2006; 21 (Suppl. 01) S11-S15
  PubMedGoogle Scholar
• 6 Nutt D, Wilson S, Paterson L. Sleep disorders as core symptoms of depression. Dialogues Clin Neurosci 2008; 10: 329-336
  PubMedGoogle Scholar
• 7 Buysse D, Angst J, Gamma A et al. Prevalence, course, and comorbidity of insomnia and depression in young adults. Sleep 2008; 31: 473-480
  PubMedGoogle Scholar
• 8 Riemann D, Voderholzer U. Primary insomnia: a risk factor to develop depression. J Affect Disord 2003; 76: 255-259
  Google Scholar
• 9 Millan MJ, Gobert A, Lejeune F et al. 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. J Pharmacol Exp Ther 2003; 306: 954-964
  CrossrefPubMedGoogle Scholar
• 10 Masana MI, Benloucif S, Dubocovich ML. Circadian rhythm of mt1 melatonin receptor expression in the suprachiasmatic nucleus of the C3H/HeN mouse. J Pineal Res 2000; 28: 185-192
  PubMedGoogle Scholar
• 11 Neu JM, Niles LP. A marked diurnal rhythm of melatonin ML1A receptor mRNA expression in the suprachiasmatic nucleus. Brain Res Mol Brain Res 1997; 49: 303-306
  CrossrefPubMedGoogle Scholar
• 12 Poirel VJ, Masson-Pevet M, Pevet P et al. MT1 melatonin receptor mRNA expression exhibits a circadian variation in the rat suprachiasmatic nuclei. Brain Res 2002; 946: 64-71
  CrossrefPubMedGoogle Scholar
• 13 Racagni G, Riva MA, Molteni R et al. Mode of action of agomelatine: synergy between melatonergic and 5-HT(2C) receptors. World J Biol Psychiatry 2011; 12: 574-587
  CrossrefPubMedGoogle Scholar
• 14 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: 109-120
  CrossrefPubMedGoogle Scholar
• 15 Olie 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: 661-673
  PubMedGoogle Scholar
• 16 Kennedy SH, Emsley R. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. Eur Neuropsychopharmacol 2006; 16: 93-100
  CrossrefPubMedGoogle Scholar
• 17 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: 329-333
  Google Scholar
• 18 Kasper S. Superior efficacy results of agomelatine in a pooled analysis versus SSRI SNRI. Eur Neuropsychopharmacol 2010; 20 (Suppl. 03) S348
  CrossrefPubMedGoogle Scholar
• 19 Hale A, Corral R, 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: 305-314
  CrossrefPubMedGoogle Scholar
• 20 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: 1723-1732
  CrossrefPubMedGoogle Scholar
• 21 Quera-Salva MA, Hajak G, Philip P et al. Comparison of agomelatine and escitalopram on nighttime sleep and daytime condition and efficacy in major depressive disorder patients. Int Clin Psychopharmacol 2011; 26: 252-262
  CrossrefPubMedGoogle Scholar
• 22 Kennedy SH, Rizvi S. Agomelatine in the treatment of major depressive disorder  −  review article. CNS Drugs 2010; 24: 479-499
  CrossrefPubMedGoogle Scholar
• 23 Möller HJ, Schnitker J. Prospective study using a modified Montgomery-Asberg Depression Scale. Nervenarzt 2007; 78: 685-690
  CrossrefPubMedGoogle Scholar
• 24 Laredo J, Quera Salva MA, Falissard B et al. Screening of sleep and circadian rhythms in major depression. J Sleep Res 2002; 11: 132-133
  PubMedGoogle Scholar
• 25 Loo H, Hale A, D’Haenen H. 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. Int Clin Psychopharmacol 2002; 17: 239-247
  CrossrefPubMedGoogle Scholar
• 26 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: 1128-1137
  CrossrefPubMedGoogle Scholar
• 27 Goodwin GM, Rouillon F, Emsley R. Long-term treatment with agomelatine:prevention of relapse in patients with major depressive disorder over 10 months. Eur Neuropsychopharmacol 2008; 18: S338
  PubMedGoogle Scholar
• 28 Kim JM, Kim SY, Stewart R et al. Improvement within 2 weeks and later treatment outcomes in patients with depressive disorders: the CRESCEND study. J Affect Disord 2011; 129: 183-190
  CrossrefPubMedGoogle Scholar
• 29 Montgomery SA, Kennedy SH, Burrows GD et al. Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with paroxetine: a randomized, double-blind, placebo-controlled discontinuation study. Int Clin Psychopharmacol 2004; 19: 271-280
  CrossrefPubMedGoogle Scholar
• 30 Laux G, Studiengruppe V. Antidepressive Therapie mit Agomelatin in der Facharztpraxis. Ergebnisse der VIVALDI-Studie. Psychopharmakotherapie 2011; 18: 18-26
  PubMedGoogle Scholar
• 31 BfArM PEI. Gemeinsame Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Planung. Durchführung und Auswertung von Anwendungsbeobachtungen (Entwurfsfassung vom 9. Mai 2007 zur Kommentierung durch die Fachöffentlichkeit) 2007
  PubMedGoogle Scholar