A comparative study of the clinical efficacy and safety of agomelatine with escitalopram in major depressive disorder patients: A randomized, parallel-group, phase IV study

Abstract

Objective:To compare the efficacy of agomelatine with escitalopram in the treatment of major depressive disorder (MDD), improve sleep in MDD patients and study the adverse effects of agomelatine.Materials and Methods:Randomized, parallel-group, open-label study. The primary efficacy outcome was change from baseline to last post-baseline value in Hamilton depression rating scale and Leeds sleep evaluation questionnaire scale. Both parametric and nonparametric tests were applied for analysis.Results:Within-group and between-groups comparison of the mean HAMD17 scores showed statistically significant changes (P < 0.0001). Escitalopram showed early onset of response and remission compared to agomelatine at 10th week (P < 0.0001) and 14th week (P < 0.0001), respectively. In agomelatine, within-group and between-groups change of the mean LSEQ score was statistically significant at subsequent follow-up visits (P < 0.0001).Conclusion:Escitalopram is superior to agomelatine in efficacy, considering the early response, early remission, and better relief from symptoms of MDD in adults. Agomelatine may be preferred in MDD patients having insomnia as a predominant symptom. Liver function monitoring should be done in patients on long-term agomelatine therapy.

Evaluation of agomelatine for the treatment of sleep problems in adults with autism spectrum disorder and co-morbid intellectual disability

“…Other studies have found significant differences in other sleep parameters (e.g. daytime sleepiness, shorter SoL) using questionnaires (Urade et al, 2015), but as our autistic adults with ID are nonverbal, questionnaires are not validated for our population. Studies in participants with mood disorders or anxiety that used subjective sleep measures have also reported an increase in TST following agomelatine treatment (Hale et al, 2010;Stein et al, 2008), and a reduction in insomnia symptoms has been observed upon agomelatine treatment (Lemoine et al, 2007).…”

Randomized controlled comparison of agomelatine and escitalopram: Concerns about study design and methods

“…They found that escitalopram had superior antidepressant effects from 6 to 24 weeks and that, during the same period, agomelatine had superior effects on sleep outcomes. [ 1 ] We have important concerns about the design and methods of this study:…”