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Journal of Pharmacology and PharmacotherapeuticsNOW IN
Article

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

Chetan S. Urade1★, Sunil M. Mahakalkar1, Prashant G. Tiple2★ Corresponding author

  1. 1Departments of Pharmacology, College, Nagpur, Maharashtra, India.
  2. 2Psychiatry, Government Medical College, Nagpur, Maharashtra, India.

CORRESPONDENCE

Chetan S. Urade

Departments of Pharmacology, College, Nagpur, Maharashtra, India.

chetanurade22@gmail.com

Received: 20-12-2014; Revised: 18-12-2014; Accepted: 29-07-2015.

Volume 6, Issue 4 · pp. 198–203 · PUBLISHED 2015 · DOI: 10.4103/0976-500X.171883

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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.

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    Urade, C. S., Mahakalkar, S. M., & Tiple, P. G. (2015). 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. Journal of Pharmacology and Pharmacotherapeutics, 6(4), 198–203. https://doi.org/10.4103/0976-500X.171883