To demonstrate the clinical effectiveness of an antidepressant drug requires evidence beyond short- and long-term efficacy, including a favourable adverse-effect profile and sustained treatment adherence. Under these conditions, patients should experience enhanced social and functional outcomes. The novel antidepressant agomelatine, a melatonergic MT(1)/MT(2) receptor agonist with serotonin 5-HT(2C) receptor antagonist activity, displays antidepressant efficacy with a favourable adverse-effect profile that is associated with good patient adherence. Specifically, agomelatine has demonstrated significant short-term (6-8 weeks) and sustained (6 months) antidepressant efficacy relative to placebo, as well as evidence of relapse prevention (up to 10 months). In head-to-head comparative studies with venlafaxine and sertraline, there was evidence of early (at 1-2 weeks) and sustained (at 6 months) advantages for agomelatine. In addition to evidence of early efficacy, agomelatine also restored disturbed sleep-wake patterns early in treatment. There was no evidence of antidepressant-induced sexual dysfunction, weight gain or discontinuation-emergent symptoms. Agomelatine has demonstrated a range of properties that suggest it could offer advantages over current treatments for major depressive disorder, although further comparative trials are still required, as is evidence from real-world clinical practice.
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"It is also important to use validated instruments that can provide a baseline to detect SD and measure change over time. To date, only a few studies have explored the impact of antidepressants on populations free of depressed symptoms (Abler et al., 2011; Kennedy et al., 1996; Montejo et al., 2010; Nafziger et al., 1999). One of these studies, using the validated Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ) (Montejo et al., 2000), has confirmed in healthy men the better sexual acceptability profile of agomelatine compared to the selective serotonin reuptake inhibitor (SSRI) paroxetine (Montejo et al., 2010). "
"Moreover, these apparently negative attributes suggest a greater risk of breakthrough depressive symptoms than other antidepressants because of a lack of sustained binding to its neurobiological target, unless multiple daily dosing is applied. Nevertheless, as noted earlier, agomelatine has as yet not been associated with ADS (Chanrion et al., 2008; Aloyo et al., 2009), while 25–50 mg agomelatine once daily is as effective an antidepressant as comparator antidepressants (Kennedy and Rizvi, 2010). Despite the reasons already described earlier validating its low risk for inducing ADS, the latter paradox prompts further discussion on the pharmacokinetic and pharmacodynamic characteristics of agomelatine. "
"The efficacy of agomelatine has been the subject of a number of clinical trials.15,32–39 In this open-label study of agomelatine monotherapy in patients with moderate to severe major depressive disorder, MADRS scores and CGI-S scores decreased significantly as early as the first week of treatment and this improvement continued over 8 weeks of treatment. "
[Show abstract][Hide abstract] ABSTRACT: Agomelatine is a novel antidepressant agonist to MT1 and MT2 subtypes of melatoninergic receptors (MT1 and MT2) and antagonist to 5-HT2C subtype of serotonergic (5-HT2C) receptors, which has shown antidepressant efficacy in short-term and long-term trials as well as in clinical practice. The purpose of this study was to assess the antidepressant efficacy, safety, and the influence of agomelatine on the functioning of patient in common clinical practice.
In this open-label, 8-week, multicenter, Phase IV trial, 111 patients with mainly moderate to severe major depressive disorder (39% treatment-naïve) were treated with agomelatine 25-50 mg/day for up to 8 weeks. The primary endpoint was the mean change in total Montgomery and Åsberg Depression Rating Scale (MADRS). Secondary endpoints included assessment of clinical response (defined as a reduction in total MADRS score of ≥50%), and change in Clinical Global Impression scales, Global Assessment of Functioning scale, Sheehan Disability Scale, and CircScreen sleep questionnaire scores. Safety and tolerability were also monitored.
Of the 111 patients enrolled, 94 completed the study. The total MADRS score significantly decreased by the first week of treatment and continued to decline significantly until study completion, with an estimated mean change of 3.9 ± 3.9 and 17.2 ± 8.0 at the first and eighth week of the study (last observation carried forward analyses). All other secondary endpoints significantly improved from early treatment evaluation to study completion. A clinical response was observed in 14.1% of patients after the first week, rising to 74.5% of patients at study completion. There were 31 spontaneously reported adverse events in 17 patients, and most were mild to moderate in severity.
This study showed good short-term efficacy for agomelatine in outpatients with major depressive episodes. Treatment with agomelatine achieved early and consistent responses for symptoms of depression and other dimensions of clinical and functional status. Agomelatine achieved significant improvements in daily functioning of patients, and had good tolerability. Clinically, no hepatic events were observed.