Agomelatine in unipolar depression in clinical practice: a retrospective chart review

Abstract

Agomelatine (Valdoxan), a synthetic melatonergic receptor agonist at the MT 1 and MT 2 receptors, was first used in the management of sleep disorder. Its 5HT2C receptor antagonistic properties support its antidepressant potential. It is currently licensed in the UK, Europe and USA for the treatment of major depressive disorder. Although the randomized controlled evidence base for its use is growing, there are no retrospective, naturalistic studies available. We aimed to determine the tolerability and clinical effectiveness of agomelatine in unipolar depression. We also examined whether being refractory to treatment altered clinical outcome. Forty-eight patient records were examined. Twenty-five percent were treatment refractory: Clinical Global Impression (CGI) Severity score at the start of treatment was 3.81 compared with 3.38 at the end of treatment. Fifty-four percent improved at least minimally; only 12.5% were much or very much improved. Treatment-refractory patients had a poorer outcome with higher discontinuation rates and lower CGI Improvement (p = 0.0205). Treatment-refractory patients also had a higher CGI Severity score at the end of treatment than at treatment commencement (3.92 versus 3.75), although this was not statistically significant.

Comparison of agomelatine and selective serotonin reuptake inhibitors/serotonin–norepinephrine reuptake inhibitors in major depressive disorder: A meta-analysis of head-to-head randomized clinical trials

“…Thus, 29 full-text manuscripts were retrieved for detailed evaluation. Of these, 23 were excluded for the following reasons: five papers were excluded because they were review articles (Carney and Shelton, 2011;Di Giannantonio and Martinotti, 2012;Hickie and Rogers, 2011;Howland, 2011;McAllister-Williams et al, 2010); eight papers were excluded because they were not headto-head trials (European Medicines Agency, 2008 (CL3-022, CL3-023, and CL3-024 trials); Kennedy and Emsley, 2006;Lôo et al, 2002;Novartis, 2009;Stahl et al, 2010;Zajecka et al, 2010); three papers were excluded because they were discontinuation studies (Goodwin et al, 2009;Montgomery et al, 2004;Novartis, 2010); four papers were excluded because they were open-label studies (Di Giannantonio et al, 2011;Langan et al, 2011;Laux, 2012;Quera Salva et al, 2007); two papers were excluded because they did not provide data for meta-analysis: Martinotti et al, 2012 (open-label study) and Stein et al, 2013 (anxiety symptoms in major depression); one paper was excluded because there were no relevant outcomes (Karaiskos et al, 2013; open-label study, comorbid diabetes mellitus). Finally, six studies (1871 patients) were retained for full data extraction for the meta-analysis.…”

Depressive disorders: Processes leading to neurogeneration and potential novel treatments

“…Superiority was reported over several other drugs both as an antidepressant and in restoring sleep Guilleminault, 2005;Ivanov and Samushiya, 2014;Kasper et al, 2013;Kennedy and Eisfeld, 2007;Martinotti et al, 2012;Owen, 2009). However, the findings have been multiply reviewed, with variable judgments (Anonymous, 2013; Bourin and Prica, 2009;Demyttenaere, 2011;Dolder et al, 2008;Eser et al, 2009Eser et al, , 2007Goodwin, 2009;Guaiana et al, 2013;Howland, 2011aHowland, , 2011bKaminski-Hartenthaler et al, 2015;Kennedy, 2009;Koesters et al, 2013;Langan et al, 2011;MacIsaac et al, 2014;Pandi-Perumal et al, 2008;Singh et al, 2012;Taylor et al, 2014). While positive opinions prevailed especially in the earlier publications, an increasing number of critical or negative conclusions were present later, especially in the larger meta-analyses.…”